A prospective, randomized, double-blind evaluation of trigger-point injection therapy for low-back pain

The efficacy of trigger-point injection therapy in treatment of low-back strain was evaluated in a prospective, randomized, double-blind study. The patient population consisted of 63 individuals with low-back strain. Patients with this diagnosis had nonradiating low-back pain, normal neurologic examination, absence of tension signs, and lumbosacral roentgenograms interpreted as being within normal limits. They were treated conservatively for 4 weeks before entering the study. Injection therapy was of four different types: lidocaine, lidocaine combined with a steroid, acupuncture, and vapocoolant spray with acupressure. Results indicated that therapy without injected medication (63% improvement rate) was at least as effective as therapy with drug injection (42% improvement rate), at a P value of 0.09. Trigger-point therapy seems to be a useful adjunct in treatment of low-back strain. The injected substance apparently is not the critical factor, since direct mechanical stimulus to the trigger-point seems to give symptomatic relief equal to that of treatment with various types of injected medication.     

Intraoperative systemic infusion of lidocaine reduces postoperative pain after lumbar surgery: a double-blinded,randomized, placebo-controlled clinical trial

Background contextAnalgesic effect of lidocaine infusion on postoperative pain.PurposeThe aim of this study was to evaluate the analgesic effect of lidocaine infusion on postoperative pain after lumbar microdiscectomy.Study designThis study used a prospective, randomized, double-blinded, and placebo-controlled clinical trial.Patient sampleFifty-one patients participated in this randomized, double-blinded study.Outcome measuresThe primary outcome was the visual analog scale (VAS) (0–100 mm) pain score at 4 hours after surgery. The secondary outcomes were the VAS pain score at 2, 8, 12, 24, and 48 hours after surgery, the frequency with which patients pushed the button (FPB) of the patient-controlled analgesia system, and the fentanyl consumption at 2, 4, 8, 12, 24, and 48 hours after surgery. Other outcomes were satisfaction scores regarding pain control and the overall recovery process, incidence of postoperative nausea and vomiting (PONV), and length of hospital stay (HS).MethodsPreoperatively and throughout the surgery, Group L received intravenous lidocaine infusion (a 1.5-mg/kg bolus followed by a 2-mg/kg/h infusion until the end of the surgical procedure) and Group C received normal saline infusion as a placebo.ResultsThe VAS scores and fentanyl consumption were significantly lower in Group L compared with Group C except at 48 h after surgery (p<.05). Total fentanyl consumption, total FPB, length of HS, and satisfaction scores were also significantly lower in Group L compared with Group C (p<.05).ConclusionsIntraoperative systemic infusion of lidocaine decreases pain perception during microdiscectomy, thus reducing the consumption of opioid and the severity of postoperative pain. This effect contributes to reduce the length of HS.     

The clinical efficacy of kinesio tape for shoulder pain: a randomized, double-blinded, clinical trial

STUDY DESIGN: Prospective, randomized, double-blinded, clinical trial using a repeated-measures design. OBJECTIVES: To determine the short-term clinical efficacy of Kinesio Tape (KT) when applied to college students with shoulder pain, as compared to a sham tape application. BACKGROUND: Tape is commonly used as an adjunct for treatment and prevention of musculoskeletal injuries. A majority of tape applications that are reported in the literature involve nonstretch tape. The KT method has gained significant popularity in recent years, but there is a paucity of evidence on its use. METHODS AND MEASURES: Forty-two subjects clinically diagnosed with rotator cuff tendonitis/impingement were randomly assigned to 1 of 2 groups: therapeutic KT group or sham KT group. Subjects wore the tape for 2 consecutive 3-day intervals. Self-reported pain and disability and pain-free active ranges of motion (ROM) were measured at multiple intervals to assess for differences between groups. RESULTS: The therapeutic KT group showed immediate improvement in pain-free shoulder abduction (mean +/- SD increase, 16.9 degrees +/- 23.2 degrees ; P = .005) after tape application. No other differences between groups regarding ROM, pain, or disability scores at any time interval were found. CONCLUSION: KT may be of some assistance to clinicians in improving pain-free active ROM immediately after tape application for patients with shoulder pain. Utilization of KT for decreasing pain intensity or disability for young patients with suspected shoulder tendonitis/impingement is not supported. LEVEL OF EVIDENCE: Therapy, level 1b-.     

Post-laparoscopic cholecystectomy pain: effects of intraperitoneal local anesthetics on pain control--a randomized prospective double-blinded placebo-controlled trial

Postoperative pain after laparoscopic cholecystectomy (LC) is generally less than open cholecystectomy; however, the postoperative shoulder and abdominal pain experienced by patients still causes preventable distress. Intraperitoneal irrigation of the diaphragmatic surface and gallbladder fossa using normal saline, bupivacaine, or lignocaine may effectively control visceral abdominal pain after an LC. Two hundred patients with similar demographics undergoing elective LC were randomized to one of four groups of 50 patients each, including Group A placebo control, Group B with isotonic saline irrigation, Group C with bupivacaine irrigation, and Group D with lignocaine irrigation. All patients received preperitoneal abdominal wall infiltration with 0.25 per cent bupivacaine to control parietal (somatic) abdominal pain. The visual analogue and verbal rating pain scores at 0, 4, 8, 12 and 24 hours for both shoulder and abdominal pain were recorded in a prospective double-blind fashion at four points during the first 24 postoperative hours. Analgesia requirements, vital signs, blood glucose, and incidence of nausea and vomiting were also recorded. Patients in each group demonstrated a significant difference in visual analogue and verbal rating pain scores and analgesic consumption when compared with controls. Lignocaine controlled pain significantly better than saline or bupivacaine. Bowel function recovery was similar in all patients, and there were no significant complications. We conclude that intraperitoneal irrigation with either saline, bupivacaine, or lignocaine can significantly reduce visceral abdominal pain after LC. Lignocaine was the most efficacious local anesthetic in this trial and has a high safety profile when used at recommended doses.     

Preoperative oral rofecoxib and postoperative pain in patients after laparoscopic cholecystectomy: a prospective, randomized, double-blinded, placebo-controlled trial

Cyclooxygenase-2 (COX-2) inhibitors are a class of drugs that may avoid some of the side effects of narcotics and nonsteroidal anti-inflammatory drugs (NSAIDs). We performed a randomized, double-blinded, placebo-controlled trial giving a single oral dose of the COX-2 inhibitor rofecoxib 25 mg or placebo preoperatively to determine the impact upon postoperative pain, complications, narcotic use, and hospital stay after laparoscopic cholecystectomy. Investigators and patients were blinded. Pain was measured on a 10-point visual analogue scale. Eighty patients were randomized: 40 to the rofecoxib group and 40 to the placebo group. The amount of pain between the two groups postoperatively was equivalent. Pain was recorded at 1 hour, 4.03 +/- 1.93 in the rofecoxib group versus 4.38 +/- 1.34 in the placebo group (P = 0.36); at 6 hours, 3.00 +/- 1.12 in the rofecoxib group versus 2.78 +/- 0.78 in the placebo group (P = 0.42); and at 24 hours, 1.64 +/- 0.67 in the rofecoxib group versus 2.68 +/- 1.90 in the placebo group (P = 0.17). The amount of pain medication received and lengths of hospital stay was not significantly different between the two groups. Our data demonstrate no significant benefit of preoperative oral rofecoxib in patients undergoing laparoscopic cholecystectomy.     

Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial

Background Laparoscopic strategies for managing intraabdominal pathologies offer significant benefits compared with conventional approaches. Of interest are reports of decreased postoperative pain, resulting in shorter hospitalization and earlier return to normal activity. However, many patients still require strong analgesia postoperatively. This study analyzed the use of intraoperatively delivered aerosolized intraperitoneal bupivacaine and its ability to reduce postoperative pain. Methods For this study, 80 patients undergoing laparoscopic cholecystectomy were recruited and divided randomly into four groups: control (n = 20), aerosolized bupivacaine (n = 20), aerosolized normal saline (n = 20), and local bupivacaine in the bladder bed (n = 20). All the patients had standard preoperative, intraoperative, and postoperative care. Pain scores were recorded by the nursing staff in recovery, then 6, 12, and 24 h postoperatively using a standard 0 to 10 pain scoring scale. In addition, opiate consumption and oral analgesia were recorded. Results Aerosolized bupivacaine significantly reduced postoperative pain in comparison with all other treatments (p < 0.05). Injection of bupivacaine into the gallbladder bed did not result in a significant difference from the control condition. Conclusion Aerosolized intraperitoneal local anesthetic is an effective method for controlling postoperative pain. It significantly helped to reduce opiate use and contributed to rapid mobilization, leading to short hospitalization and possible reduction in treatment cost.     

A prospective, randomized, double-blinded comparison of ropivacaine 0.5%, 0.75%, and 1% ropivacaine for peribulbar block.

STUDY OBJECTIVE: To evaluate the efficacy of three different concentrations of ropivacaine (0.5%, 0.75%, and 1%) together with a single concentration of hyaluronidase administered for peribulbar block. DESIGN: Prospective, randomized, double-blind study. SETTING: Anesthesia department of a university teaching hospital. PATIENTS: 68 ASA physical status I, II, and III patients undergoing elective cataract surgery. INTERVENTIONS: Patients were randomly allocated to receive peribulbar block with 6.5 mL of either 0.5% (Group Ropi-5; n = 22), 0.75% (Group Ropi-7.5; n = 22), or 1% ropivacaine (Group Ropi-10; n = 24). In all patients, 0.5 mL of hyaluronidase was added to the local anesthetic solution. MEASUREMENTS AND MAIN RESULTS: A larger proportion of patients in Groups Ropi-7.5 (82%) and Ropi-10 (83%) showed complete motor block 15 minutes after injection compared with Group Ropi-5 (55%;p = 0.05, andp = 0.03, respectively). Hypotension (reduction of systolic blood pressure by 30% or more from baseline) was observed in two Group Ropi-5 patients (9%), and two Group Ropi-7.5 patients (9%;p = 0.31), whereas bradycardia (reduction in heart rate < or = 50 bpm) was observed in one Group Ropi-5 patient (4%), and three Group Ropi-10 patients (12%;p = 0.18). Seven hours after surgery, a smaller proportion of Group Ropi-10 patients (64%) showed complete recovery of sensory function as compared with both Group Ropi-5 (94%) and Group Ropi-7.5 (90%;p = 0.03 and p = 0.03, respectively). Complete recovery of motor function 1 hour after surgery was more frequent in Group Ropi-5 (37%) than in Group Ropi-7.5 (5%) or Group Ropi-10 (9%;p = 0.05 and p = 0.05, respectively); however, no other differences in recovery of motor function were observed at any other observation times, with complete recovery in all patients 7 hours after surgery. CONCLUSIONS: While confirming that ropivacaine is a good option for peribulbar anesthesia, this study demonstrated that the use of 0.75% or 1% concentrations are preferred in that they produce quick and deep sensory and motor block of the operated eye. If recovery of normal motor function is important after surgery, the 0.75% concentration probably represents the best compromise.     

The economic impact of laparoscopic inguinal hernia repair: results of a double-blinded,prospective, randomized trial

For this study, 66 patients with a preoperative diagnosis of unilateral primary inguinal hernia were randomized to undergo laparoscopic totally extra peritoneal (TEP), laparoscopic transabdominal (TAPP), or open inguinal hernia repair with polypropylene mesh (Lichtenstein type). Both the operative team caring for the patient postoperatively and the patient were blinded to the operative approach by placement of a large dressing covering the abdomen, which was not removed until postoperative day 3. The patients recorded their pain level on a visual analog pain scale daily. Medication usage also was recorded. All patients were seen at 7-day intervals until they returned to work. The patients were interviewed during their postoperative visits by an investigator blinded to the operative approach and questioned regarding their ability to return to work and their pain levels. The average number of lost work days in all the groups was 12, and there was no significant difference between the three groups (p = 0.074). The average operating time for the TAPP procedure was 59 min, less than the time required to complete either the TEP or the Lichtenstein approach, which had equivalent operative times (p = 0.027). The material cost was significantly lower for the Lichtenstein repair ($1,200 less) than for either of the laparoscopic approaches, a saving primarily related to consumable operating room supplies. The TEP repair costs were minimally higher than those for the TAPP repair ($125 more). No significant differences were noted in the postoperative pain scales, and the use of postoperative oral analgesics was equivalent. The higher operative costs noted for the laparoscopic hernia repairs were not offset by a shortened convalescence. Postoperative pain appears to be equivalent regardless of the operative approach chosen and is easily managed with oral analgesics. Presented at the 2003 Society of the American Gastrointestinal and Endoscopic Surgeons (SAGES) Annual Meeting March 12–15, Los Angeles, CA     

Systemic lidocaine shortens length of hospital stay after colorectal surgery: a double-blinded, randomized, placebo-controlled trial

OBJECTIVE: To characterize the beneficial effects of perioperative systemic lidocaine on length of hospital stay, gastrointestinal motility, and the inflammatory response after colorectal surgery. SUMMARY BACKGROUND DATA: Surgery-induced stimulation of the inflammatory response plays a major role in the development of several postoperative disorders. Local anesthetics possess anti-inflammatory activity and are thought to positively affect patients' outcome after surgery. This double-blinded, randomized, and placebo-controlled trial aimed to evaluate beneficial effects of systemic lidocaine and to provide insights into underlying mechanisms. METHODS: Sixty patients undergoing colorectal surgery, not willing or unable to receive an epidural catheter, were randomly assigned to lidocaine or placebo treatment. Before induction of general anesthesia, an intravenous lidocaine bolus (1.5 mg/kg) was administered followed by a continuous lidocaine infusion (2 mg/min) until 4 hours postoperatively. Length of hospital stay, gastrointestinal motility, and pain scores were recorded and plasma levels or expression of pro- and anti-inflammatory mediators determined. RESULTS: Lidocaine significantly accelerated return of bowel function and shortened length of hospital stay by one day. No difference could be observed in daily pain ratings. Elevated plasma levels of IL-6, IL-8, complement C3a, and IL-1ra as well as expression of CD11b, L- and P-selectin, and platelet-leukocyte aggregates were significantly attenuated by systemic lidocaine. CONCLUSIONS: Perioperative intravenous lidocaine not only improved gastrointestinal motility but also shortened length of hospital stay significantly. Anti-inflammatory activity modulating the surgery-induced stress response may be one potential mechanism. Systemic lidocaine may thus provide a convenient and inexpensive approach to improve outcome for patients not suitable for epidural anesthesia.     

Prehospital analgesia with acupressure in victims of minor trauma: a prospective,randomized, double-blinded trial

Untreated pain during the transportation of patients after minor trauma is a common problem in emergency medicine. Because paramedics usually are not allowed to perform invasive procedures or to give drugs for pain treatment, a noninvasive, nondrug-based method would be helpful. Acupressure is a traditional Chinese treatment for pain that is based on pain relief followed by a short mechanical stimulation of specific points. Consequently, we tested the hypothesis that effective pain therapy is possible by paramedics who are trained in acupressure. In a double-blinded trial we included 60 trauma patients. We randomly assigned them into three groups ("true points," "sham-points," and "no acupressure"). An independent observer, blinded to the treatment assignment, recorded vital variables and visual analog scales for pain and anxiety before and after treatment. At the end of transport, we asked for ratings of overall satisfaction. For statistical evaluation, one-way analysis of variance and the Scheffé F test were used. P < 0.05 was considered statistically significant. Morphometric and demographic data and potential confounding factors such as age, sex, pain, anxiety, blood pressure, and heart rate before treatment did not differ among the groups. At the end of transport we found significantly less pain, anxiety, and heart rate and a greater satisfaction in the "true points" groups (P < 0.01). Our results show that acupressure is an effective and simple-to-learn treatment of pain in emergency trauma care and leads to an improvement of the quality of care in emergency transport. We suggest that this technique is easy to learn and risk free and may improve paramedic-based rescue systems. IMPLICATIONS: We tested, in a double-blinded manner, the hypothesis that acupressure could be an effective pain therapy in minor-trauma patients. Our results show that acupressure is an effective and simple-to-learn treatment of pain in emergency medical care and can improve the quality of care.     

Topical 2% amitriptyline and 1% ketamine in neuropathic pain syndromes: a randomized, double-blind, placebo-controlled trial

BACKGROUND: A double-blind, randomized, placebo-controlled 3-week study evaluated the efficacy of topical 2% amitriptyline, 1% ketamine, and a combination of both in treating patients with neuropathic pain. METHODS: Ninety-two patients with diabetic neuropathy, postherpetic neuralgia, or postsurgical/posttraumatic neuropathic pain with allodynia, hyperalgesia, or pinprick hypesthesia were randomly assigned to receive one of four creams (placebo, 2% amitriptyline, 1% ketamine, or 2% amitriptyline-1% ketamine combined). The primary outcome measure was change in average daily pain intensity (baseline week vs. final week) using an 11-point numerical pain rating scale. Secondary outcomes included the McGill Pain Questionnaire, measures of allodynia and hyperalgesia, and patient satisfaction. RESULTS: A reduction in pain scores of 1.1-1.5 units was observed in all groups, and there was no difference between groups. Blood concentrations revealed no significant systemic absorption. Minimal side effects were encountered. CONCLUSION: This randomized, placebo-controlled trial examining topical 2% amitriptyline, 1% ketamine, and a combination in the treatment of neuropathic pain revealed no difference between groups. Optimization of doses may be required, because another study has revealed that higher concentrations of these agents combined do produce significant analgesia.     

Preincision 0.25% bupivacaine scalp infiltration and postcraniotomy pain: a randomized double-blind,placebo-controlled study

This prospective, double-blind, randomized, and placebo-controlled trial was performed to evaluate the effect of preincisional scalp infiltration with 0.25% bupivacaine on the postoperative pain perception and analgesic requirement of patients undergoing elective supratentorial craniotomy. Twenty patients (bupivacaine group) received scalp infiltration with 25 mL of 0.25% bupivacaine followed by intravenous 5 mL of saline as placebo 5 minutes before incision, and another 21 patients (fentanyl group) received scalp infiltration with a similar volume of 0.9% saline solution followed by 2 microg/kg of intravenous fentanyl 5 minutes before incision. Following standard anesthesia technique, basal, preincisional, and postincisional hemodynamic data were recorded. Postoperative pain was assessed at 1, 6, 12, 24, and 48 hours by using a 10-cm visual analog scale. Diclofenac sodium was used as rescue analgesic in the postoperative period. Results showed rescue analgesic was required only during the first 12 hours. In each group the same number of patients needed rescue analgesia, but bupivacaine delayed this requirement 105 (30-720; median [range]) minutes compared with 60 (15-720; median [range]) minutes for the fentanyl group (P = 0.13). But there was no difference in the amount of analgesic consumed at different time intervals. Six of 20 patients in the bupivacaine group required rescue analgesic at the end of 1 hour compared with 9 of 21 fentanyl patients (P = 0.61). At 6 hours, the fraction of patients who required rescue analgesia were 7 of 20 and 11 of 21, respectively (P = 0.44). In conclusion, bupivacaine preincision scalp infiltration did not have any significant effect on postcraniotomy pain and analgesic requirement. However, bupivacaine may delay the requirement of the first analgesic dose.