Dataset Information

Effects of neuraxial blockade may be difficult to study using large randomized controlled trials: the PeriOperative Epidural Trial (POET) Pilot Study.

ABSTRACT:

Background

Early randomized controlled trials have suggested that neuraxial blockade may reduce cardiorespiratory complications after non-cardiothoracic surgery, but recent larger trials have been inconclusive. We conducted a pilot study to assess the feasibility of conducting a large multicentre randomized controlled trial in Canada.

Methodology/principal findings

After Research Ethics Board approvals from the participating institutions, subjects were recruited if they were > or = 45 years old, had an expected hospital stay > or = 48 hours, were undergoing a noncardiothoracic procedure amenable to epidural analgesia, met one of six risk criteria, and did not have contraindications to neuraxial blockade. After informed consent, subjects were randomly allocated to combined epidural analgesia (epidural group) and neuraxial anesthesia, with or without general anesthesia, or intravenous opioid analgesia (IV group) and general anesthesia. The primary outcomes were the rate of recruitment and the percents of eligible patients recruited, crossed over, and followed completely. Feasibility targets were defined a priori. A blinded, independent committee adjudicated the secondary clinical outcomes. Subjects were followed daily while in hospital and then at 30 days after surgery. Analysis was intention-to-treat. Over a 15-month period, the recruitment rate was 0.5+/-0.3 (mean+/-SEM) subjects per week per centre; 112/494 (22.7%) eligible subjects were recruited at four tertiary-care teaching hospitals in Canada. Thirteen (26.5%) of 49 subjects in the epidural group crossed over to the IV group; seven (14.3%) were due to failed or inadequate analgesia or complications from epidural analgesia. Five (9.8%) of 51 subjects in the IV group crossed over to the epidural group but none were due to inadequate analgesia or complications. Ninety-eight (97.0%) of 101 subjects were successfully followed up until 30 days after their surgery.

Conclusion/significance

Of the criteria we defined for the feasibility of a full-scale trial, only the follow-up target was met. The other feasibility outcomes did not meet our preset criteria for success. The results suggest that a large multicentre trial may not be a feasible design to study the perioperative effects of neuraxial blockade.

Trial registration

ClinicalTrials.gov NCT 0221260 Controlled-Trials.com ISRCTN 35629817.

SUBMITTER: Choi PT

PROVIDER: S-EPMC2645707 | biostudies-literature | 2009

REPOSITORIES: biostudies-literature

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Publications

Effects of neuraxial blockade may be difficult to study using large randomized controlled trials: the PeriOperative Epidural Trial (POET) Pilot Study.

Choi Peter T PT Beattie W Scott WS Bryson Gregory L GL Paul James E JE Yang Homer H

PloS one 20090227 2

<h4>Background</h4>Early randomized controlled trials have suggested that neuraxial blockade may reduce cardiorespiratory complications after non-cardiothoracic surgery, but recent larger trials have been inconclusive. We conducted a pilot study to assess the feasibility of conducting a large multicentre randomized controlled trial in Canada.<h4>Methodology/principal findings</h4>After Research Ethics Board approvals from the participating institutions, subjects were recruited if they were > or ...[more]

PMID: 19247497

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Project description:BackgroundDexmedetomidine, a highly selective α2-adrenoceptor agonist, has been investigated for anti-shivering effects in some trials. This current meta-analysis was conducted to evaluate the effectiveness of dexmedetomidine as a neuraxial adjuvant in preventing perioperative shivering.MethodsThis systematic review and meta-analysis was registered in PROSPERO [www.crd.york.ac.uk/PROSPERO] with the unique identification number CRD42017055991. The electronic databases PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL) were searched to select high-quality randomized controlled trials (RCTs) that evaluated the anti-shivering efficacy for neuraxial application dexmedetomidine as local anesthetic adjuvant. Effects were summarized using pooled risk ratios (RRs), weighed mean differences (MDs), or standardized mean differences (SMDs) and corresponding 95% confidence intervals (Cls) with random effect model. Heterogeneity assessment, sensitivity analysis, and publication bias were performed. The primary outcome was perioperative shivering.ResultsA total of 1760 patients from 24 studies were included in this meta-analysis. Compared with the placebo, dexmedetomidine reduced the incidence of perioperative shivering (RR: 0.34; 95% Cl: 0.21 to 0.55; P < 0.00001), with a maximum effective dose of 5μg via subarachnoid space injection (RR: 0.55; 95% CI: 0.32 to 0.92; P = 0.02), especially in cesarean section (RR: 0.20; 95% CI: 0.09 to 0.45; P = 0.0001). Dexmedetomidine also could improve the characteristics of the block, with an increase only in the incidence of bradycardia (RR: 2.11; 95% CI: 1.23 to 3.60; P = 0.006). No significant difference could be found compared dexmedetomidine with other adjuvants, except morphine.ConclusionsThis meta-analysis shows that dexmedetomidine as a neuraxial adjuvant had statistically significant efficacy on prevention of perioperative shivering. Moreover, dexmedetomidine could improve the characteristics of the block. However, the potential induction of bradycardia should be taken seriously.

Project description:BACKGROUND AND OBJECTIVES:The use of patient-controlled epidural analgesia after various operations has been associated with an early return of bowel function, thus decreasing patients' length of stay (LOS). The primary aim of this study was to compare LOS after radical cystectomy between patients who received epidural analgesia versus those who received intravenous patient-controlled analgesia. Our secondary analysis included the assessment of other metrics such as total opioid requirements, pain scores, return of bowel function, and complication rates between the 2 groups. METHODS:We conducted a retrospective review using the electronic medical records of 308 patients who underwent radical cystectomies at Memorial Sloan Kettering between 2006 and 2011. We aimed to understand if epidural analgesia was associated with a reduced LOS compared with patient-controlled intravenous opioid analgesia. We also aimed to identify performance improvements as a function of epidural analgesia status using various metrics such as pain management, bowel function return, and complication rates. We used both univariate and multivariate analyses to identify if epidural analgesia was associated with meaningful differences in the aforementioned metrics. RESULTS:Median age at radical cystectomy, body mass index, sex, American Society of Anesthesiologists score, and T stage were similar for both groups. For our primary objective of LOS, we found no significant difference between the 2 cohorts (8 vs 7 days, P = 0.2). Analysis of our secondary outcome measures revealed that epidural analgesia use was associated with less total opioid requirement for the first 3 postoperative days (PODs) (P = 0.0001). In addition, epidural analgesia was found to be associated with improved postoperative pain scores compared with intravenous patient-controlled analgesia on PODs 1 (P = 0.0001) and 2 (P = 0.004), and there was a slight improvement on POD 3, but this was not significant (P = 0.77). In contrast, we found no difference between pain management types with regard to proportion of patients who experienced a delay in gastrointestinal recovery, fluid bolus requirements within the first 3 perioperative days, rates of infection, pulmonary complications, and grade 3 or greater complications. CONCLUSIONS:We have demonstrated that, despite significant improvements in initial pain control and less opioid requirement with patient-controlled epidural analgesia, there was no association between analgesic approach and LOS, return of bowel function, or complications.

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Dataset Information

Effects of neuraxial blockade may be difficult to study using large randomized controlled trials: the PeriOperative Epidural Trial (POET) Pilot Study.

Background

Methodology/principal findings

Conclusion/significance

Trial registration

Publications

Effects of neuraxial blockade may be difficult to study using large randomized controlled trials: the PeriOperative Epidural Trial (POET) Pilot Study.

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