A multicenter,randomized, controlled trial comparing bupivacaine with ropivacaine for labor analgesia

BACKGROUND: A meta-analysis of studies comparing high doses of bupivacaine with ropivacaine for labor pain found a higher incidence of forceps deliveries, motor block, and poorer neonatal outcome with bupivacaine. The purpose of this study was to determine if there is a difference in these outcomes when a low concentration of patient-controlled epidural bupivacaine combined with fentanyl is compared with ropivacaine combined with fentanyl. METHODS: This was a multicenter, randomized, controlled trial, including term, nulliparous women undergoing induction of labor. For the initiation of analgesia, patients were randomized to receive either 15 ml bupivacaine, 0.1%, or 15 ml ropivacaine, 0.1%, each with 5 microg/ml fentanyl. Analgesia was maintained with patient-controlled analgesia with either local anesthetic, 0.08%, with 2 microg/ml fentanyl. The primary outcome was the incidence of operative delivery. We also examined other obstetric, neonatal, and analgesic outcomes. RESULTS: There was no difference in the incidence of operative delivery between the two groups (148 of 276 bupivacaine recipients vs. 135 of 279 ropivacaine recipients; P = 0.25) or any obstetric or neonatal outcome. The incidence of motor block was significantly increased in the bupivacaine group compared with the ropivacaine group at 6 h (47 of 93 vs. 29 of 93, respectively; P = 0.006) and 10 h (29 of 47 vs. 16 of 41, respectively; P = 0.03) after injection. Satisfaction with mobility was higher with ropivacaine than with bupivacaine (mean +/- SD: 76 +/- 23 vs. 72 +/- 23, respectively; P = 0.013). Satisfaction for analgesia at delivery was higher for bupivacaine than for ropivacaine (mean +/- SD: 71 +/- 25 vs. 66 +/- 26, respectively; P = 0.037). CONCLUSIONS: There was no difference in the incidence of operative delivery or neonatal outcome among nulliparous patients who received low concentrations of bupivacaine or ropivacaine for labor analgesia.     

A controlled randomized multicenter trial of pancreatogastrostomy or pancreatojejunostomy after pancreatoduodenectomy

BACKGROUND: Only 2 large (more than 100 patients) prospective trials comparing pancreatogastrostomy (PG) with pancreatojejunostomy (PJ) after pancreatoduodenectomy (PD) have been reported until now. One nonrandomized study showed that there were less pancreatic and digestive tract fistula with PG, whereas the other, a randomized trial from a single high-volume center, found no significant differences between the two techniques. METHODS: Single blind, controlled randomized, multicenter trial. The main endpoint was intra-abdominal complications (IACs). RESULTS: Of 149 randomized patients, 81 underwent PG and 68 PJ. No significant difference was found between the two groups concerning pre- or intraoperative patient characteristics. The rate of patients with one or more IACs was 34% in each group. Twenty-seven patients sustained a pancreatoenteric fistula (18%), 13 in PG (16%; 95% confidence interval [CI] 8-24%) and 14 in PJ (20%; 95% CI 10.5-29.5%). No statistically significant difference was found between the 2 groups concerning the mortality rate (11% overall), the rate of reoperations and/or postoperative interventional radiology drainages (23%), or the length of hospital stay (median 20.5 days). Univariate analysis found the following risk factors: (1) age > or =70 years old, (2) extrapancreatic disease, (3) normal consistency of pancreas, (4) diameter of main pancreatic duct <3 mm, (5) duration of operation >6 hours, and (6) a center effect. Significantly more IAC, pancreatoenteric fistula, and deaths occurred in one center (that included the most patients) (P = .05), but there were significantly more high-risk patients in this center (normal pancreas consistency, extrapancreatic pathology, small pancreatic duct, higher transfusion requirements, and duration of operation >6 hours) compared with the other centers. In multivariate analysis, the center effect disappeared. Independent risk factors included duration of operation >6 hours for IAC and for pancreatoenteric fistula (P = .01), extrapancreatic disease for pancreatoenteric fistulas (P < .04), and age > or =70 years for mortality (P < .02). CONCLUSIONS: The type of pancreatoenteric anastomosis (PJ or PG) after PD does not significantly influence the rate of patients with one or more IAC and/or pancreatic fistula or the severity of complications.     

Blood volume controlled hemodialysis in hypotension-prone patients: a randomized,multicenter controlled trial

BACKGROUND: Recently we have devised and tested a biofeedback system for controlling blood volume (BV) changes during hemodialysis (HD) along an ideal trajectory (blood volume tracking, BVT), continuously modifying the weight loss rate and dialysate conductivity. This multicenter, prospective, randomized, crossover study aimed to clarify whether BVT (treatment B) can improve hypotension-prone patients' treatment tolerance, compared with conventional hemodialysis (treatment A). METHODS: Thirty-six hypotension-prone patients enrolled from 10 hemodialysis (HD) centers were randomly assigned to either of the study sequences ABAB or BABA, each lasting four months. RESULTS: A 30% reduction in intradialytic hypotension (IDH) events was observed in treatment B as compared with A (23.5% vs. 33.5%, P = 0.004). The reduction was related to the number of IDH in treatment A (y = 0.54x + 5; r = 0.4; P < 0.001): the more IDH episodes in treatment A, the better the response in treatment B. The best responders to treatment B showed pre-dialysis systolic blood pressure values higher than the poor responders (P = 0.04). A 10% overall reduction in inter-dialysis symptoms was obtained also in treatment B compared to A (P < 0.001). Body weight gain, pre-dialysis blood pressure, intradialytic weight loss as well as Kt/V did not differ between the two treatments. CONCLUSIONS: An overall improvement in the treatment tolerance was observed with BVT, particularly intradialytic cardiovascular stability. Patients with the highest incidence of IDH during conventional HD and free from chronic pre-dialysis hypotension seem to respond better. Inter-dialysis symptoms also seem to improve with control of BV.     

国产低能冲击波设备治疗勃起功能障碍的多中心随机对照研究

目的评估国产线性低能冲击波设备(E100)治疗勃起功能障(ED)的安全性和有效性。方法本研究为一多中心、随机双盲对照研究。病史、国际勃起功能评分(IIEF-6)及夜间阴茎勃起监测确诊的ED患者,按照2︰1的顺序随机分为治疗组及对照组,接受低能冲击波治疗每周1次,共4周,能量0.09mJ/mm2;分4个部位,每部位冲击900次,共3600次,对照组在探头内置铁片阻挡冲击波输出,其余与治疗组完全相同。治疗结束后12周随访,内容包括IIEF-6及夜间阴茎勃起监测。结果治疗组40例中的35例,对照组20例中的16例完成治疗及随访。治疗组与对照组在基线年龄、身高、IIEF-6等均无显著差异;治疗组IIEF-6随访结果显著优于对照组(17.60±6.18 vs.14.00±6.13);治疗组有效率显著高于对照组(68.6%vs.12.5%)。两组均无副作用报告。结论国产低能冲击波设备(E100)治疗勃起功能障碍安全、有效。     

Beneficial effect of additional cardioplegia flush during hypothermic static cardiac preservation

BACKGROUND: The effects of various preservative solutions and methods have been studied to prolong the safety period of cardiac preservation. In this study, we used cardioplegic solution (CS) during cardiac preservation and investigated how flush CS yields good preservation of isolated hearts compared with only cold immersion. METHODS: Male Wistar rat hearts were arrested with 4 degrees C St. Thomas crystalloid CS. All hearts were immersed for 6 hr in a 4 degrees C Euro-Collins solution. Hearts were classified into seven groups by period and number of infusions of CS (20 ml/kg) during simple immersion of hearts. Infusion of CS during preservation was not used for group I. Infusion was performed at two hours after starting immersion for group II, at 3 hr for group III, at 4 hr for group IV, at 5 hr for group V, every hour for group VI, and every 2 hr for group VII. After preservation, the hearts were reperfused with blood using a support rat. Myocardial adenosine triphosphate was measured immediately after immersion of hearts. Biochemical examination of coronary effluents was performed at 15 min after reperfusion, and cardiac function was evaluated at 40 min after reperfusion. Myocardial specimens were subsequently taken for measurement of water content. RESULTS: Percentage recovery of left ventricular developed pressure and dp/dt in groups III, VI, and VII were higher than those in group I at each balloon volume, and left ventricular end-diastolic pressure in these groups was also significantly lower than that in group I. Levels of creatine kinase-MB and lactate in groups VI and VII after reperfusion were significantly lower than those in group I. Myocardial adenosine triphosphate was significantly better preserved in groups III, IV, VI, and VII than in group I. However, no significant difference in cardiac function or myocardial adenosine triphosphate was found among groups III, IV, VI, and VII. CONCLUSIONS: The use of CS during cardiac preservation is effective in preserving cardiac function and myocardial enzymes, and infusion may be sufficient if performed once-only at 3 or 4 hr from starting immersion in 6 hr storage of isolated rat hearts.     

A multicenter randomized controlled trial comparing patient-controlled epidural with intravenous analgesia for pain relief in labor

In this multicenter, randomized, controlled trial, we sought to determine whether patient-controlled epidural analgesia (PCEA) for labor affected the incidence of cesarean delivery when compared with patient-controlled IV opioid analgesia (PCIA). Healthy, term nulliparous patients in 4 Canadian institutions were randomly assigned to receive PCIA with fentanyl (n = 118) or PCEA with 0.08% bupivacaine and fentanyl 1.6 microg/mL (n = 124). There was no difference in the incidence of cesarean delivery-10.2% (12 of 118) versus 9.7% (12 of 124)-or instrumental vaginal delivery-21.2% (25 of 118) versus 29% (36 of 124)-between groups. The duration of the second stage of labor was increased in the PCEA group by a median of 23 min (P = 0.02). Fifty-one patients (43%) in the PCIA group received epidural analgesia: 39 (33%) because of inadequate pain relief and 12 (10%) to facilitate operative delivery. Patients in the PCIA group required more antiemetic therapy (17% versus 6.4%; P = 0.01) and had more sedation (39% versus 5%; P < 0.001). Maternal mean pain and satisfaction with analgesia scores were better in the PCEA group (P < 0.001 and P = 0.02, respectively). More neonates in the PCIA group required active resuscitation (52% versus 31%; P = 0.001) and naloxone (17% versus 3%; P < 0.001). These observations support the hypothesis that PCEA does not result in an increased incidence of obstetrical intervention compared with PCIA. PCEA provides superior analgesia and less maternal and neonatal sedation compared with PCIA.     

Wound drain in lumbar arthrodesis for degenerative disease: an experimental,multicenter, randomized controlled trial

INTRODUCTIONDrains for surgical wound management are frequently used in spine surgery. They are often used to decrease the incidence of postoperative hematoma and decrease wound tension. No conclusive evidence in the literature supports using drains to avoid complications in degenerative lumbar spine surgery.PURPOSEWe aimed to evaluate wound drains in patients with lumbar arthrodesis for degenerative disorders based on clinical outcomes, complications, hematocrit, and length of stay.STUDY DESIGNA multicenter randomized prospective controlled clinical trial.PATIENT SAMPLEWe enrolled surgical candidates for posterior lumbar decompression and fusion surgery for degenerative disorders from October 2019 to August 2021. Patients were randomized into the drain or nondrain group at nine hospitals. The inclusion criteria were as follows: patients aged 40 to 80 years with lumbar and radicular pain, lumbar degenerative disorder, and primary surgery up to three levels. The exclusion criteria were bleeding abnormalities, bleeding >2,500 mL and dural tears.OUTCOME MEASURESPreoperative data including Oswestry disability index (ODI), SF-36, lumbar and lower extremity visual analog scale (VAS), body mass index (BMI), hematocrit, and temperature were recorded. Surgical parameters, including surgical time, complications, estimated blood loss (EBL), postoperative temperature and hematocrit (days 1 and 4), dressing saturation, and length of hospital stay (LOS), were registered.METHODSThe two groups were assessed preoperatively, perioperatively and at the 1-month follow-up. A REDCap database was used for registration. Data analysis was performed using classical statistics.RESULTSOne hundred one patients were enrolled using the Redcap database, and 93 patients were evaluated at the final follow-up. Forty-five patients were randomized to the drain group, and 48 were randomized to the nondrain group. The preoperative characteristics were equivalent in both groups: demographic aspects, pain, ODI, SF-36, BMI, hematocrit, and spine pathology. Surgical time, EBL and complications were similar, with no difference between the groups. No difference was found between BMI and complications. No difference was observed in dressing saturation or postoperative temperature between the groups. The postoperative day 4 hematocrit was higher in the nondrain group [36.4% (32–39)] than in the drain group [34% (29.7–37.6)] without statistically differences (p=.054). The LOS was higher in the drain group [4 (3–5) days] than in the nondrain group [3 (2–4) days] (p=.007). The quality-of-life score, SF-36, was higher in the nondrain group [67.9 (53.6–79.2)] than in the drain group [56.7 (49.1–66)] (p=.043).CONCLUSIONSNondrain patients presented shorter LOS and better outcomes, with similar complication rates. No difference was found between BMI and complications. Based on this study, in patients undergoing primary posterior spinal decompression and fusion up to three levels for degenerative lumbar disorders, we do not recommend the use of postoperative drains.     

A randomized controlled trial of larval therapy for the debridement of leg ulcers: Results of a multicenter,randomized, controlled,open, observer blind,parallel group study

It has been known for centuries that the application of larvae is useful to heal certain wounds by facilitating debridement of necrotic tissue,¹ yet the efficacy of larval therapy continues to be debatable. This study compared the clinical effectiveness of a larval therapy dressing (BioFOAM) with a standard debridement technique (Purilon gel; hydrogel) in terms of time to debridement of venous (VLU) or mixed arterial/venous (MLU) leg ulcers. Data analyses were conducted on 88 subjects. Sixty‐four subjects completed the full study. Of these, 31 of the 32 (96.9%) patients who completed treatment in the larvae arm debrided fully, compared with 11 of the 32 (34.4%) patients who completed the hydrogel arm. In addition, 42 (48%) ulcers fully debrided within the 21‐day intervention phase, 31 (67.4%) from the larvae arm (n = 46), and 11 (26.2%) from the hydrogel arm (n = 42), which was statistically significant (p = 0.001) in support of larvae. A statistically significant difference was also observed between treatment arms with regard to numbers of dressing changes during the intervention phase of the study (p < 0.001) in that subjects in the larvae arm required significantly fewer dressing changes(mean = 2.83) than those in the hydrogel arm (mean = 5.40). There were no statistically significant differences in the clinical condition of the wound bed and surrounding skin by intervention. Subjects in the larvae arm experienced more ulcer‐related pain or discomfort than subjects in the hydrogel arm (p < 0.001). This study provided good evidence to show that larval therapy, in the form of a BioFOAM dressing, debrided VLU and MLU considerably more quickly than a hydrogel, although the possibility of resloughing should be closely monitored.     

Perioperative goal-directed therapy in high-risk abdominal surgery. A multicenter randomized controlled superiority trial

Study objectiveThe potential of perioperative goal-directed therapy (PGDT) to improve outcome after high-risk abdominal surgery remains subject of debate. In particular, there is a need for large, multicenter trials focusing on relevant patient outcomes to confirm the evidence found in small, single center studies including minor complications in their composite endpoints. The present study therefore aims to investigate the effect of an arterial waveform analysis based PGDT algorithm on the incidence of major complications including mortality after high-risk abdominal surgery.DesignProspective randomized controlled multicenter trial.SettingOperating theatres and Post-Anesthesia/Intensive Care units (PACU/ICU) of four tertiary hospitals in The Netherlands.PatientsA total number of 482 patients undergoing elective, abdominal surgery that is considered high-risk due to the extent of the procedure and/or patient comorbidities.InterventionsHemodynamic therapy using an age-specific PGDT algorithm including cardiac index (CI) and stroke volume variation (SVV) measurements during a 24-h perioperative period starting at induction of anesthesia.MeasurementsThe average number of major complications (including mortality) within 30 days after surgery, the number of minor complications, hospital and PACU/ICU length of stay (LOS), amounts of fluids and vasoactive medications used. Complications were graded using the Accordion severity grading system.ResultsThe average number of major complications per patient was 0.79 (PGDT group) versus 0.69 (control group) (p = 0.195). There were no statistically significant differences in the number of minor complications, hospital LOS, PACU/ICU LOS, or grading of complications. Patients in the PGDT group received more fluids intraoperatively, more dobutamine intra- and postoperatively, while patients in the control group received more phenylephrine during the operation.ConclusionsPGDT based on a CI and SVV driven algorithm did not result in improved outcomes after high-risk abdominal surgery.Clinical trial registrationNetherlands Trial Registry: NTR3380.     

Remote transmission monitoring for postoperative perineural analgesia after major orthopedic surgery: A multicenter,randomized, parallel-group,controlled trial

Study objectiveAfter surgery, patients reported the delay in receiving help as the primary factor for poorly controlled pain. This study aimed to compare the effectiveness of patient management through two communication modalities: remote transmission (RT) versus bedside control (BC). We hypothesized that using remote technology for pump programming may provide the best postoperative infusion regimen for the patient's self-assessment of pain and adverse events.DesignA multicenter, randomized, parallel-group, controlled trial.SettingAnesthesiology department and orthopedic surgery ward at three university hospitals.PatientsEighty patients undergoing orthopedic surgery with postoperative perineural patient-controlled analgesia were included.InterventionsTwo groups (n = 40 for each group) were formed by randomization. In the postoperative period, perineural analgesia was followed up via an RT system or BC for 72 h.MeasurementsA nurse assessed daily pain, sensory and motor blocks and adverse events. Patients completed a questionnaire three times a day and alerted for any problem according to the group (RT system or nurses' follow-up). On the third postoperative day, the nurse removed the catheter, completed the final assessment, and collected the historical data from the pump. A physician's shorter response time to change the patient control analgesia (PCA) program was the primary endpoint.ResultsOf the 80 patients, 71 were analyzed (34 were randomized to the RT group and 37 to the BC group). Fifty-eight pump setting changes were noted. Analysis of repeated evaluations shows that mean time (SD) to change the PCA pump settings was significantly lower in the RT group (20 min (22.3 min)) than in the BC group (55.9 min (71.1 min)); mean difference [95% CI], −35.9 min [−74.3 to 2.4]); β estimation [95% CI], −34 [−63 to −6], p = 0.011). Pain relief, sensory and motor blocks did not differ between the groups: β estimation [95% CI], 0.1 [−0.4 to 0.6], p = 0.753; 0.5 [−0.4 to 1.4], p = 0.255; 0.9 [−0.04 to 1.8], p = 0.687, respectively. β = −34 [−63 to −6], p = 0.011). The consumption of ropivacaine, nurse workload and the cost of the analgesia regimen decreased in the RT group. No differences were noted in satisfaction scores or complication rates.ConclusionsThe response time for the physician to change the PCA program when necessary was shorter for patients using RT and alerts to the physician were more frequent compared with spot checks by nurses. RT helps to decrease nurses' workload, ropivacaine consumption, and costs but did not affect postoperative pain relief, complication rate, or patient-reported satisfaction score.IRB contact informationComité de Protection des Personnes, Sud Méditerranée III, Montpellier-Nîmes, France, registration number EudraCT A01698-35.Clinical trial numberClinicalTrials.gov ID:NCT02018068ProtocolThe full trial protocol can be accessed at Department of Anesthesiology and Critical Care Medicine, Medical Research and Statistics Unit, Lapeyronie University Hospital, Avenue Doten G Giraud, Montpellier, France. s-bringuierbranchereau@chu-montpellier.fr     

Closure of lacerations and incisions with octylcyanoacrylate: a multicenter randomized controlled trial

BACKGROUND: Most lacerations and surgical incisions are closed with sutures or staples. Octylcyanoacrylate tissue adhesive (OCA) was recently approved for use in the United States. We compared the cosmetic appearance of lacerations and incisions repaired with OCA versus standard wound closure methods (SWC). METHODS: A multicenter randomized clinical trial including patients with simple lacerations or surgical incisions was conducted at 10 clinical sites. Patients were randomly assigned to treatment with OCA or SWC. Follow-up was performed at 1 week and at 3 months to determine infection rates and cosmetic outcome. RESULTS: Eight hundred fourteen patients with 924 wounds (383 traumatic lacerations, 235 excisions of skin lesions or scar revisions, 208 minimally invasive surgeries, and 98 general surgical procedures) were enrolled. Groups were similar in baseline characteristics. Wound closure with OCA was faster than with SWC (2.9 vs 5.2 minutes, P <.001). At 1 week infection rates were similar (OCA, 2.1% vs SWC, 0.7%; P =.09) and fewer OCA wounds were erythematous (18% vs 36%, P <.001). There were no differences in wound dehiscence rates (OCA, 1.6% vs SWC, 0.9%; P =.35). At 3 months there was no difference in the percent of wounds with optimal appearance (OCA, 82% vs SWC, 83%; P =.67). CONCLUSIONS: Repair of traumatic lacerations and surgical incisions with OCA is faster than with SWC, and cosmetic outcome is similar at 3 months.     

A randomized controlled trial of N-acetylcysteine to prevent contrast nephropathy in cardiac angiography

BACKGROUND: Contrast nephropathy (CN) is a common cause of renal dysfunction after cardiac angiography. Recently, N-acetylcysteine (NAC) has been found to reduce the risk of CN after CT imaging with contrast enhancement. The purpose of the current study was to evaluate the efficacy of NAC for the prevention of CN in the setting of cardiac angiography. METHODS: Eligible patients were those undergoing cardiac angiography with serum creatinine>1.7 mg/dL. Patients were randomized to one of two groups: Group 1, IV hydration and NAC, 1200 mg one hour before angiography, and a second dose 3 hours after; Group 2, IV hydration and placebo. CN was defined as an increase of 0.5 mg/dL in serum creatinine. RESULTS: Seventy-nine patients completed the study. There were no significant differences between the groups in baseline characteristics, duration of angiography, mean volume of dye infused or mean IV hydration. Contrast nephropathy developed in 24.0% of subjects, 26.3% NAC, and 22.0% placebo (P = NS). Among subjects with diabetes mellitus, there was no significant difference in the rate of CN between the groups (42.1% NAC, 27.8% placebo; P = 0.09). The independent predictors of CN risk were diabetes mellitus and preexisting chronic renal insufficiency. CONCLUSIONS: NAC was not effective for the prevention of CN after cardiac angiography.