A double-blind placebo-controlled comparison of a novel formulation of intravenous diclofenac and ketorolac for postoperative third molar extraction pain

Dyloject is a novel formulation of diclofenac intended for intravenous (IV) administration. This formulation employs the solubilizing agent hydroxypropyl-β-cyclodextrin to permit bolus IV administration. The efficacy and safety of 5 dose levels of IV diclofenac were compared with IV ketorolac and placebo following third molar extraction. This was a single-dose, randomized, double-blind, placebo- and comparator-controlled, parallel-group study. A total of 353 subjects with moderate to severe pain received placebo; ketorolac 30 mg; or IV diclofenac 3.75, 9.4, 18.75, 37.5, or 75 mg (N = 51 for all groups, except N = 47 for ketorolac). The primary endpoint was total pain relief over 6 hours (TOTPAR6) as measured by the visual analog scale (VAS). Secondary endpoints included multiple measures of pain intensity and relief; patient global evaluation; and times to pain relief and rescue medication. Dropouts and adverse effects (AEs) were also monitored. IV diclofenac was superior to placebo as measured by TOTPAR6 (P < .0001 for all doses except 3.75 mg, for which P = .0341). IV diclofenac 3.75 mg was statistically superior to placebo for TOTPAR2 and TOTPAR4. IV diclofenac at both 37.5 and 75 mg was superior to placebo (P < .05) at the earliest (5 minute) assessments of pain intensity and pain relief, but ketorolac was not. The proportion of patients reporting 30% or greater pain relief at 5 minutes was significantly greater after IV diclofenac 37.5 and 75 mg than after ketorolac 30 mg or placebo. Secondary endpoints confirmed the primary findings. Treatment-related AEs were generally mild to moderate and were typical for nonsteroidal anti-inflammatory drugs (NSAIDs). The more rapid onset of action of IV diclofenac compared with the reference injectable NSAID ketorolac suggests additional clinical benefit. If confirmed in larger series, these findings may improve the safety and efficacy of postoperative NSAID analgesia.     

Intravenous ketorolac vs diclofenac for analgesia after maxillofacial surgery

Purpose

To compare the efficacy of the nonsteroidal antiinflammatory drugs (NSAID), ketorolac and diclofenac in prevention of pain after maxillofacial surgery.

Methods

Sixty ASA I– II patients (30 in each group) received randomly, and double blindly either ketorolac 0.4 mg · kg^{? 1} or diclofenac 1.0 mg · kg^{? 1} iv after general anaesthesia induction, before surgical incision. In the ketorolac group, the same dose was repeated iv three times at six hour intervals. The diclofenac group patients received diclofenac 1.0 mg μ kg^{? 1} after 12 hr iv. Rescue analgesic medication consisting of oxycodone 0.03 mg · kg^{? 1} iv, was administered by a patient controlled analgesia apparatus.

Results

Two patients in the ketorolac and three patients in the diclofenac group did not need oxycodone during the study period. On average, 12 and 11 doses of oxycodone were needed in the ketorolac and the diclofenac groups, respectively (NS). Sideeffects were similar in both groups. All patients except one were satisfied with the pain therapy.

Conclusion

Parenteral ketorolac (0.4 mg · kg^{? 1} four times in 24 hr) and diclofenac (1 mg · kg^{? 1} twice in 24 hr) were similar, but insufficient alone, for analgesia after maxillofacial surgery.     

Optimal dose of succinylcholine for tracheal intubation in patients during inhalation induction with sevoflurane: a randomized controlled trial

Study ObjectiveTo determine the dose of succinylcholine during inhalation induction of a patient.DesignedProspective, double-blind, randomized study.SettingOperating room of a university hospital.Patients180 adult, ASA physical status 1 and 2 patients with a suspected difficult airway, who were scheduled for surgery.InterventionsNonpremedicated patients were anesthetized with inhalation of 8% sevoflurane, followed by succinylcholine. Group 1 received intravenous (IV) succinylcholine 0.3 mg/kg, Group 2 had IV succinylcholine 0.6 mg/kg, and Group 3 was given IV succinylcholine 1.0 mg/kg. Direct laryngoscopy and tracheal intubation were performed after onset of succinylcholine.MeasurementsIntubation conditions were scored as excellent, good, or poor. The recovery time of spontaneous respiration, end-tidal carbon dioxide partial pressure (P_ETCO₂), and pulse oxygen saturation (SpO₂) were recorded.Main ResultsAcceptable conditions (excellent and good) for intubation were rated in 80% of Group 1 patients (0.3 mg/kg succhinylcholine), 91.7% of Group 2 patients (0.6 mg/kg), and 93.3% of Group 3 patients (1.0 mg/kg), respectively. Intubation scores were similar in Groups 2 and 3, and were significantly higher than in Group 1 patients (0.3 mg; P < 0.01). Time to recovery of spontaneous respiration in Group 3 was significantly prolonged compared with Groups 1 and 2 (238 ± 59 sec vs 132 ± 43 sec, P < 0.001; 238 ± 59 sec vs 151 ± 47 sec, P < 0.001, respectively). SpO₂ in Group 3 did not differ significantly from Group 1 and 2 values. However, P_ETCO₂ in Group 3 was significantly higher than in Groups 1 or 2.ConclusionsSuccinylcholine at a dose of 0.6 mg/kg IV provided intubation conditions similar to succinylcholine at 1.0 mg/kg IV, and recovery of spontaneous respiration following a 0.6 mg/kg dose of succinylcholine was significantly shorter.     

A placebo-controlled,double-blind,randomized study of single-dose intravenous diclofenac for pain relief after a cesarean section

BackgroundThis study was conducted to avoid the pain of an intramuscular injection of diclofenac after a cesarean section, by modifying it to an intravenous infusion by diluting it with 5% dextrose in 100 mL of water.ObjectiveThe aim of this study was to determine the efficacy of a single-dose modified diclofenac being given intravenously, instead of intramuscularly, for pain relief after a cesarean section.Study designA double-blind, randomized controlled trial was conducted.ParticipantsWe enrolled 30 patients who underwent cesarean sections with Pfannenstiel skin incision.MethodsAll patients received 2.2–2.5 mL of 0.5% bupivacaine with 0.2 mg morphine for spinal anesthesia. The participants were equally and randomly allocated to two groups to receive intravenous diclofenac or placebo at 12 hours postoperatively. Both groups received the same regimen for postoperative pain control.Main outcome measurementsThe severity of postoperative pain was measured directly using a verbal numerical rating scale (0–10) and a pain-relief scale (1–4), and indirectly from the amount of tramadol used.ResultsThe characteristics of the two groups of patients were similar. The mean postoperative pain relief at 24 hours in the study group was better than that in the control group (3.14 ± 0.66 vs. 2.13 ± 0.99; p < 0.05). The severity of postoperative pain at 24 hours and the amount of tramadol used were not different between groups.ConclusionIntramuscular diclofenac (75 mg), modified by diluting it with 5% dextrose in 100 mL of water, for intravenous administration in combination with spinal morphine (0.2 mg) provided good analgesia after a cesarean section within 24 hours when assessed by the pain-relief scale; however, the mean pain intensity was not different.     

In Vitro Effect of Clinical Propofol Concentrations on Platelet Aggregation

The inhibitory effect of propofol on platelet aggregation remains unclear, and studies on the subject disagree. Furthermore, although propofol infusions are widely used for general anesthesia and as sedatives for patients in intensive care units, little information is available on its concentration‐ and time‐related effects on platelet aggregation. Here, the authors investigated the in vitro effect of propofol, at concentrations required for sedation and general anesthesia, on platelet aggregation after 1, 2, or 3 h. Blood from healthy volunteers (n = 9) was incubated at propofol plasma concentrations of 0, 2, 4, and 10 μg/mL in a water bath at 37°C. Platelet aggregation was measured using a platelet function analyzer (PFA‐100) after 1, 2, or 3 h of incubation. Times to occlude collagen/epinephrine (CEPI) or collagen/adenosine 5'‐diphosphate (CADP)‐coated membranes (closure times, CTs) were measured. The CEPI and CADP CTs of non‐incubated blood were 125.6 ± 19.5 s and 93.0 ± 12.2 s, respectively, and no significant difference in CEPI CTs was observed at propofol plasma concentrations of 0, 2, 4, and 10 μg/mL after incubation for 1, 2, or 3 h. CADP CTs were comparable at propofol concentrations of 0, 2, 4, and 10 μg/mL at each incubation time. These findings suggest that propofol at concentrations required for sedation and general anesthesia has no inhibitory effect on platelet aggregation after 3 h of incubation.     

Neostigmine injected 5 minutes after low-dose rocuronium accelerates the recovery of neuromuscular function

Study ObjectiveTo determine whether neostigmine 5 minutes after 0.4 mg/kg rocuronium accelerates reversal.DesignProspective, randomized, comparative open-label study.SettingOperating room.Patients60 ASA physical status I and II patients, aged 18 to 65 years.InterventionsPatients received 0.4 mg/kg rocuronium during nitrous oxide (N₂O)-propofol-opioid anesthesia. Reversal of neuromuscular blockade was achieved with neostigmine, either at 0.03 mg/kg or 0.05 mg/kg intravenously (IV), together with glycopyrrolate administered 5 minutes after relaxant and compared with spontaneous recovery. Onset, depth, and duration of neuromuscular block, as well as recovery of train-of-four (TOF) to 0.8 and 0.9 were evaluated.Main ResultsTimes to achieve TOF ratios of 0.8 and 0.9 were significantly shorter when 0.03 mg/kg or 0.05 mg/kg neostigmine was administered 5 minutes after administration of rocuronium (20.2 ± 5 min and 22.6 ± 5.9 min or 17.8 ± 4.8 min and 19.4 ± 5.1 min, respectively) compared with controls (36.2 ± 8.5 min and 39.0 ± 8.7 min; P < 0.01). Duration to spontaneous T1 25% recovery after rocuronium was 15.5 ± 6.5 min versus 9.3 ± 2.3 min and 7.7 ± 1.6 min in the treatment groups (P < 0.01). Recovery index (T1 from 25% to 75%) was significantly shorter after neostigmine (7.1 ± 2.4 min and 5.7 ± 4.0 min) versus controls (13.3 ± 8.3 min; P < 0.01). Speed of reversal did not differ significantly between IV neostigmine doses of 0.03 mg/kg or 0.05 mg/kg.ConclusionNeostigmine accelerates recovery when administered 5 minutes after injection of IV rocuronium 0.4 mg/kg.     

Ketorolac, diclofenac, and ketoprofen are equally safe for pain relief after major surgery

Background. Ketorolac is approved for the relief of postoperativepain but concerns have been raised over a possible risk of seriousadverse effects and death. Two regulatory reviews in Europeon the safety of ketorolac found the data were inconclusiveand lacked comparison with other non-steroidal anti-inflammatorydrugs. The aim of this study was to compare the risk of seriousadverse effects with ketorolac vs diclofenac or ketoprofen inadult patients after elective major surgery. Methods. This prospective, randomized multicentre trial evaluatedthe risks of death, increased surgical site bleeding, gastrointestinalbleeding, acute renal failure, and allergic reactions, withketorolac vs diclofenac or ketoprofen administered accordingto their approved parenteral and oral dose and duration of treatment.Patients were followed for 30 days after surgery. Results. A total of 11 245 patients completed the trial at 49European hospitals. Of these, 5634 patients received ketorolacand 5611 patients received one of the comparators. 155 patients(1.38%) had a serious adverse outcome, with 19 deaths (0.17%),117 patients with surgical site bleeding (1.04%), 12 patientswith allergic reactions (0.12%), 10 patients with acute renalfailure (0.09%), and four patients with gastrointestinal bleeding(0.04%). There were no differences between ketorolac and ketoprofenor diclofenac. Postoperative anticoagulants increased the riskof surgical site bleeding equally with ketorolac (odds ratio=2.65,95% CI=1.51–4.67) and the comparators (odds ratio=3.58,95% CI=1.93–6.70). Other risk factors for serious adverseoutcomes were age, ASA score, and some types of surgery (plastic/ear,nose and throat, gynaecology, and urology). Conclusion. We conclude that ketorolac is as safe as ketoprofenand diclofenac for the treatment of pain after major surgery. Br J Anaesth 2002; 88: 227–33     

Effect of the intraoperative wake-up test in sevoflurane-sufentanil combined anesthesia during adolescent idiopathic scoliosis surgery: a randomized study

Study ObjectiveTo investigate the effect of the intraoperative wake-up test on sevoflurane-sufentanil anesthesia for adolescent idiopathic scoliosis (AIS) surgery.DesignRandomized, double-blind, parallel trial.SettingOperating room.Patients30 ASA physical status 1 patients, aged 13 to 20 years, scheduled for AIS surgery.InterventionsPatients were randomized to two groups: Group W patients received sevoflurane-sufentanil combined anesthesia and underwent the intraoperative wake-up test; Group NW received sevoflurane-sufentanil combined anesthesia without the wake-up test. Anesthesia was induced with an intravenous (IV) injection of midazolam, propofol, and sufentanil and maintained with sevoflurane inhalation, a target-controlled infusion (TCI) of sufentanil, and IV infusion of cisatracurium besylate.MeasurementsThe primary outcome was postoperative delirium. Secondary outcomes were duration of surgery, duration of anesthesia, intraoperative blood loss and transfusion, exposure of drugs administered, time to eye opening, extubation, and consciousness.Main ResultsPostoperative delirium occurred in one patient from each group (P > 0.05). There were no significant differences between the two groups in duration of surgery (322 ± 65 min vs 336 ± 72 min), duration of anesthesia (356 ± 76 min vs 368 ± 81 min), intraoperative blood loss (1847 ± 423 mL vs 1901 ± 451 mL) and transfusion (1663 ± 398 mL vs 1649 ± 382 mL), average exposure of drugs (72 ± 13 mg vs 75 ± 15 mg for propofol, 116 ± 28 μg vs 109 ± 25 μg for sufentanil, and 22 ± 5 vs 23 ± 4 mg for cisatracurium), time to eye opening (4.7 ± 1.5 min vs 4.8 ± 1.4 min), extubation (7.5 ± 2.0 min vs 7.3 ± 2.2 min), and consciousness (8.9 ± 1.8 min vs 9.1 ± 2.1 min) (all P > 0.05).ConclusionsSevoflurane-sufentanil combined anesthesia provides hemodynamic stability and rapid recovery from AIS surgery. There is no correlation between the intraoperative wake-up test and postoperative delirium after sevoflurane-sufentanil combined anesthesia.     

Effect of the addition of clonidine to locally administered bupivacaine on acute and chronic postmastectomy pain

Study ObjectivesTo investigate the analgesic effect of adding clonidine to topical bupivacaine for acute and chronic postmastectomy pain.DesignRandomized, prospective, double-blinded study.SettingCancer institute and university hospital.Patients140 ASA physical status 1 and II women, aged 30 to 50 years, scheduled for modified radical mastectomy with axillary dissection for breast carcinoma.InterventionsPatients were divided into 4 groups of 35 patients each, to receive either saline 0. 9% (control group), plain bupivacaine 0.5% (Bupivacaine group), plain bupivacaine 0.5% and 150 μg of clonidine (Clonidine150 group), or plain bupivacaine 0.5% and 250 μg of clonidine (Clonidine250 group). Study drugs were irrigated into the surgical field before skin closure.Measurements and Main ResultsPain severity, time to first request of rescue analgesia, analgesic consumption, hemodynamics, and side effects were recorded in the first 48 hours postoperatively. The frequency of neuropathic pain was assessed using the Douleur Neuropathique 4-question survey (DN4) in the first and second postoperative months. Mean time to first postoperative analgesic request was significantly prolonged in the Bupivacaine (5.76 ± 0.85 hrs), Clonidine150 (11.6 ± 2.38 hrs), and Clonidine250 (17.4 ± 3.27 hrs) groups compared with the control group (1.86 ± 0.65 hrs). Postoperative tramadol consumption and visual analog scores (VAS) were significantly reduced in the Bupivacaine, Clonidine150, and Clonidine250 groups. Clonidine250 group patients had the lowest VAS scores from 2 to 48 hours postoperatively. Lower mean DN4 scores (P = 0.000) and a significantly reduced frequency of neuropathic pain (P < 0.04) were recorded in the Bupivacaine, Clonidine150, and Clonidine250 groups, with a nonsignificant difference noted among the treatment groups.ConclusionsThe addition of clonidine to topical bupivacaine accentuated its early postoperative analgesic efficacy.     

Comparison of the effect of intravenous ketoprofen, ketorolac and diclofenac on platelet function in volunteers

Background : Nonsteroidal anti–inflammatory drugs (NSAIDs) inhibit prostaglandin synthesis which may result in impaired platelet function. Because NSAIDs have different abilities to inhibit cyclo–oxygenases we compared the effect of intravenous ketoprofen, ketorolac and diclofenac on platelet function in volunteers. Methods : Ten healthy male volunteers were given ketoprofen 1.4 mg kg^-1, ketorolac 0.4 mg kg^-1 and diclofenac 1.1 mg kg^-1 in saline i.v. on three different occasions, at more than one–week intervals, in a randomized double–blind crossover study. Platelet function was evaluated before (sample 0), 2 (sample 2) and 24 h (sample 3) after the beginning of the infusion. Results : Two of the volunteers had no secondary platelet aggregation in their aggregation curves before the experiment (sample 0, studied three times) and their results were excluded from the final analysis. Diclofenac inhibited adrenaline (0.9 μg–ml^-1) induced platelet aggregation less (median maximal aggregation 22.5%) than ketoprofen (18.3%) and ketorolac (15.7%) (P<0.05) in sample 2. In the ketorolac group in sample 3 an impairment of adrenaline (0.9 ng ml^-1) induced platelet aggregation was still seen (26.7%) (P<0.05) but not in the other groups. Diclofenac did not affect adenosine diphosphate (ADP) induced platelet aggregation. However, ketorolac caused an impairment in ADP (3 μM and 6 μM) induced platelet aggregation and ketoprofen in ADP (6 μM) induced platelet aggregation in sample 2. Bleeding time was prolonged (P<0.05) after ketoprofen and ketorolac (sample 2) but not after diclofenac. Platelet retention on glass beads was unaffected by the tested drugs. Conclusion : Ketoprofen, ketorolac and diclofenac caused a reversible platelet dysfunction. Diclofenac had the mildest effect, while platelet dysfunction was still seen 24 h after the beginning of ketorolac.     

The frequency of fentanyl-induced cough in children and its effects on tracheal intubation

Study ObjectiveTo determine if fentanyl-induced cough was dose-dependent in children and whether it could affect tracheal intubation.DesignProspective, randomized, double-blinded study.SettingOperating room of a university-affiliated hospital.Patients160 ASA physical status I pediatric patients, aged two to 14 years, scheduled for elective surgery during general anesthesia and requiring orotracheal intubation.InterventionsPatients were divided into two groups. Group 1 patients were given fentanyl at a dosage of one μg/kg; Group 2 patients received two μg/kg of fentanyl. Induction of anesthesia was conducted immediately following cough cessation or one minute after the end of injection with propofol 2.5 mg/kg. At loss of eyelash reflex, rocuronium 0.6 mg/kg was given intravenously (IV). Two minutes later, tracheal intubation was started.MeasurementsOnset and degree of cough and intubating conditions were observed and recorded.Main ResultsNo statistically significant differences in frequency of coughing or in intubating conditions between the two groups were noted. Cough severity in Group 1 was statistically lower than that of Group 2 (P < 0.05). Onset of cough in Group 2 (12.2 ± 3.4 sec) was statistically shorter than in Group 1 (16.9 ± 7.6 sec, P < 0.05).ConclusionFentanyl at doses of one and two μg/kg may induce coughing in pediatric patients.     

Effect of preemptive and preventive acetaminophen on postoperative pain score: a randomized,double-blind trial of patients undergoing lower extremity surgery

Study ObjectiveTo compare postoperative pain scores and rescue analgesic use in patients who received acetaminophen preoperatively or during skin closure versus those who received a placebo.DesignRandomized, double-blind clinical trial.SettingUniversity-based, tertiary-care hospital.Patients75 adult, ASA physical status 1 and 2 undergoing lower extremity orthopedic surgery.InterventionsPatients were randomized to three groups. The control group received 100 mL of intravenous (IV) normal saline as a placebo. The preventive acetaminophen group received 100 mL of IV normal saline plus 15 mg/kg of acetaminophen prior to skin closure. The preemptive acetaminophen group received 15 mg/kg of IV acetaminophen combined with 100 mL of normal saline half an hour preoperatively.MeasurementsPain was scored with the verbal rating scale and assessed 5 minutes before spinal anesthesia, and 6, 12, 18, and 24 hours after surgery. Total rescue meperidine consumption by each patient during the first 24 hours after surgery was also recorded.Main ResultsPain scores were lower in both preemptive and preventive acetaminophen groups at 6 hours after surgery than in the placebo group (P < 0.001). There were no differences in pain scores after 6 hours between the preemptive and preventive groups. Total analgesic consumption 24 hours after surgery was lowest in the preemptive acetaminophen group (P < 0.01). Average time to initial analgesic requirement was slightly longer in the preemptive and preventive acetaminophen groups than the control group (P < 0.01).ConclusionIn patients undergoing lower extremity surgery with spinal anesthesia, both preventive and preemptive acetaminophen may enhance analgesia and decrease postoperative analgesic consumption.     

Epidural butorphanol-bupivacaine analgesia for postoperative pain relief after abdominal hysterectomy

Study ObjectiveTo determine the efficacy of epidural butorphanol with and without bupivacaine in providing postoperative analgesia following abdominal hysterectomy.DesignRandomized, double-blinded study.SettingsPostoperative recovery area of a university-affiliated medical center.Patients60 ASA physical status I and II women, aged 20-65 years, undergoing abdominal hysterectomy.InterventionsPatients were randomly allocated to three groups during the postoperative period to receive one of three epidural regimens: two mg of butorphanol in 10 mL of normal saline (Group 1), two mg of butorphanol in 10 mL of 0.125% bupivacaine (Group 2), or two mg of butorphanol in 10 mL of 0.25% bupivacaine (Group 3).MeasurementsOnset and duration of analgesia were recorded. Hemodynamic variables, pain scores, sedation scores, and respiratory rate were monitored for 24 hours. Frequency and severity of respiratory depression, sedation, pruritus, nausea, and vomiting were recorded.Main ResultsThe addition of butorphanol to bupivacaine resulted in significantly (P < 0.05) faster onset of pain relief. The duration of analgesia was prolonged in patients receiving butorphanol with bupivacaine combination (8.68 ± 0.82 hrs, 9.82 ± 0.54 hrs) as compared with butorphanol alone (4.35 ± 0.66 hrs; P < 0.05). The differences between Groups 2 and 3 were not significant.ConclusionsAddition of two mg of butorphanol to 0.125% of epidural bupivacaine resulted in rapid onset and longer duration of analgesia than did butorphanol alone.     

Low dose ketorolac infusion improves postoperative analgesia combined with patient controlled fentanyl analgesia after living donor hepatectomy – Randomized controlled trial

BackgroundHepatectomy elaborates significant post-operative pain. Opioids represent cornerstone for post-operative analgesia in such cases. This study examined the therapeutic effect and outcome of adding low dose ketorolac tromethamine infusion to PO intravenous patient controlled fentanyl analgesia IV-PCA.Patients and methodsSixty right lobe donors were randomized into either fentanyl or ketorolac groups (30 patients each). Patients in both groups received fentanyl (2 μg/ml) solution in normal saline as IV-PCA with background infusion in a rate adjusted to deliver 0.25 μg kg h^?1 and boluses of 10 ml with a lock-out time of 20 min. They received 15 mg ketorolac IV bolus in ketorolac group and similar placebo injection in the control. Patients in both groups received a continuous intravenous infusion of 240 ml normal saline solution that is either free in the FENT group or containing 60 mg ketorolac in ketorolac group, adjusted to a rate of 0.2 ml kg h^?1. Visual analogue score (VAS) and hemodynamic profile were recorded at 1, 6, 12, 24, 36 and 48 h while laboratory results were recorded after 48 h and 7 days post-operatively.ResultsVAS was significantly lower in ketorolac group compared to fentanyl group from 6 to 36 h post-operatively while sedation score was significantly higher in fentanyl group compared to fentanyl–ketorolac group between 12 and 36 h post-operatively. Fentanyl consumption was significantly lower in ketorolac group at 24 (318.7 ± 66 vs 468.3 ± 79) and 48 (211.5 ± 59 vs 369.1 ± 68) h. Hemodynamic data and laboratory parameters were comparable in both groups. Nausea had a significantly higher incidence in FENT compared to KETR groups while other complications (vomiting and blood loss) were homogenous in both groups.ConclusionAdding ketorolac to IV PCA fentanyl improved the analgesic state and reduced the dose of fentanyl used without adding any side effects or risks to donors subjected to right lobe hepatectomy.     

Bilateral multi-injection iliohypogastric-ilioinguinal nerve block in conjunction with neuraxial morphine is superior to neuraxial morphine alone for postcesarean analgesia

Study ObjectiveTo determine whether bilateral iliohypogastric and ilioinguinal (IHII) peripheral nerve blocks, given in conjunction with neuraxial morphine, reduce postcesarean analgesic requirements and side effects, resulting in improved maternal satisfaction.DesignRandomized, prospective, double-blinded, placebo-controlled study.SettingLabor and delivery suite at Johns Hopkins Hospital.Patients34 women scheduled for elective cesarean delivery.InterventionsPatients were randomized to receive IHII nerve blocks bilaterally, with either total 24 mL of 0.5% bupivacaine or normal saline, following cesarean delivery via Pfannensteil incision with a standard intrathecal dose of 12 mg of 0.75% bupivacaine with 10 µg of fentanyl and 200 µg of preservative-free morphine.MeasurementsPatients were assessed at 0, 6, 12, 18, and 24 hours postoperatively. Visual analog scale (VAS) pain scores at rest were recorded at each time period. Analgesic use, patients’ perception of nausea, vomiting, pruritus, and their overall satisfaction with their analgesia were recorded for the first 24 hours.Main ResultsLower VAS pain scores were seen in the bupivacaine group at 6, 12, 18, and 24 hours postoperatively (P = 0.01, P < 0.01, 0.02, and 0.04, respectively). A longer mean time to first rescue dose of ketorolac was noted in the bupivacaine group (14.3 ± 1.8 hrs) than the saline group (mean 5.6 ±1.1 hrs), (P < 0.01). Fewer patients in the bupivacaine group made requests for acetaminophen 500 mg/oxycodone 5 mg in the first 24 hours. Satisfaction was greater in the bupivacaine group. No difference in side effects was noted between groups.ConclusionsBilateral multilevel injection IHII nerve blocks result in lower resting VAS pain scores, lower analgesic requirements, and greater satisfaction following cesarean delivery in patients who received neuraxial morphine.     

Comparison of the morphine-sparing effects of diclofenac sodium and ketorolac tromethamine after major orthopedic surgery

STUDY OBJECTIVES: To compare the efficacy of diclofenac sodium with ketorolac tromethamine in reducing postoperative morphine use after major orthopedic surgery. DESIGN: Double-blind, randomized, placebo-controlled study. SETTING: Major teaching institution. PATIENTS: 102 ASA physical status II patients undergoing hip and knee replacement with general anesthesia. INTERVENTIONS: Before induction of anesthesia, patients were randomly allocated to receive intravenously either diclofenac sodium 75 mg (Group D), ketorolac tromethamine 60 mg (Group K), or placebo (Group P). Patient-controlled analgesia was supplied postoperatively using morphine. MEASUREMENTS: Visual analog scale (VAS), verbal pain score (VPS), sedation score, frequency of opioid side effects, and morphine consumption were recorded every 4 hours. MAIN RESULTS: There was a highly significant downward trend for VAS, VPS, and sedation scores over time, p = 0.001. The mean VAS and VPS scores were significantly lower in Groups D and K compared with Group P at time 0, p = 0.009 and 8 hours, p = 0.026. The mean (SD) 24-hour morphine requirements were 36.3 mg (16.9), 47.2 mg (34.9), and 51.6 mg (22.2) for Groups D, K, and P, respectively, p = 0.032. Fewer patients suffered from postoperative nausea and vomiting in the treatment groups (Groups D and K) compared with Group P (9, 8, and 19, respectively), p < 0.05. Fewer patients also suffered from pruritus in Groups D and K compared with Group P (3, 4, and 11, respectively), p < 0.01. CONCLUSIONS: Preoperative administration of intravenous diclofenac 75 mg or ketorolac 60 mg significantly reduces morphine requirements and associated side effects after major orthopedic surgery.     

Systemic lidocaine decreases the Bispectral Index in the presence of midazolam, but not its absence

Study ObjectiveTo evaluate the effects of intravenous (IV) lidocaine on the Bispectral Index (BIS) in the presence or absence of midazolam.DesignProspective, randomized, double-blinded, placebo-controlled clinical study.SettingOperating room of a university hospital.Patients96 ASA physical status 1, 2, and 3 patients undergoing general anesthesia.InterventionsPatients were assigned to one of 6 treatment groups to receive IV midazolam (0.03 mg/kg) or placebo, followed 5 minutes later by one of three IV preinduction doses of lidocaine: 0.5, 1.0, or 1.5 mg/kg.MeasurementsBIS values were recorded before administration of lidocaine and at 30-second intervals afterwards for three minutes. The primary endpoint was the average BIS level recorded.Main ResultsBaseline BIS values were lower in the midazolam group (94 ± 4 vs. 90 ± 7, P < 0.001). There was no significant decrease in BIS values in the placebo group for any of the three lidocaine doses. However, in the midazolam groups, significant decreases in BIS levels versus baseline values were measured.ConclusionIV lidocaine decreases BIS in the presence of midazolam, suggesting that the effect of lidocaine on BIS is not direct, but rather results from modulation by midazolam.     

Intravenous vs Oral Acetaminophen as an Adjunct to Multimodal Analgesia After Total Knee Arthroplasty: A Prospective,Randomized, Double-Blind Clinical Trial

Background

The efficacy of intravenous (IV) acetaminophen compared with its oral formulation for postoperative analgesia is unknown. We hypothesized that the addition of acetaminophen to a multimodal analgesia regimen would provide improved pain management in patients after total knee arthroplasty (TKA) and that the effect of acetaminophen would be variable based on the route of delivery.