Continuous Preperitoneal Infusion of Local Anesthetic (CPA) Versus Epidural Infusion of Local Anesthetic (EA) in Fast-Track Open Colorectal Surgery

Phase 4

• Conditions: Early Rehabilitation After Surgery; Open Colorectal Surgery

• Registration Number: NCT00915265
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

The purpose of this study is to compare the continuous preperitoneal infusion of local anesthetic and continuous epidural analgesia for postoperative pain management in fast-track open colorectal surgery.

Detailed Description

Optimized pain relief allowing early mobilization is a prerequisite for enhanced recovery after surgery. Open colorectal surgery is associated with severe and prolonged postoperative pain, especially during mobilization. No analgesic technique has fulfilled all requirements of optimal efficacy: no side effects, low costs, high patient compliance, and improvement in outcome, and consequently, multimodal analgesic techniques have been introduced with a focus on opioid sparing to improve analgesia and recovery. Epidural analgesia (EA) has shown a marked benefit in controlling pain at mobilization, and significantly improves pain management when compared with systemic patient-controlled morphine analgesia. However, eligible patients may not benefit from it because of technical problems or failure of efficiency. Recently, continuous preperitoneal infusion of local anesthetic (CPA) has been shown to be an effective method to relief pain after open colorectal surgery, to reduced morphine consumption and accelerated postoperative recovery. However, this technique has never been evaluated in a fast-track program (ERAS protocol). Moreover, continuous preperitoneal infusions of local anesthetic and epidural analgesia have never been compared.

The purpose of this randomized and double-blinded study is to compare these two techniques on pain control during mobilization, as a prerequisite for enhanced recovery after open colorectal surgery: 1- CPA group: continuous preperitoneal administration of 0.2% ropivacaine using a multilobed catheter positioned between the previously closed parietal peritoneum and the underside of the transversalis fascia + intravenous morphine (patient-controlled analgesia, PCA) as a rescue; 2- EA group: epidural infusion of 0.2% ropivacaine (patient-controlled epidural analgesia, PCEA) + continuous preperitoneal administration of 0.9% saline.

Study Timeline

• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-08
• Study Start: 2009-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-01-31
• Primary Completion: 2018-07
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age > 18 years
• Open colorectal surgery through a midline incision with a primary anastomosis
• American Society of Anesthesiologists (ASA) physical status I to III

Exclusion Criteria

• Obesity (body mass index > 35 kg/m2)
• Pregnancy
• Inflammatory bowel diseases
• Contraindication for epidural analgesia (patient refusal, active sepsis, coagulopathy)
• Chronic renal failure (with creatinin clearance < 30 ml/min)
• Significant hepatic failure (prothrombin ratio < 50%, factor V < 50%)
• Chronic pain
• Preoperative opioid consumption
• Preoperative cognitive dysfunction
• Preoperative psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain measured at mobilization (defined as pain experienced during transition from supine to the sitting position) using the visual analogue pain scale (VAS) from 0 (no pain) to 10 (worst pain imaginable), at 24 hour after tracheal extubation (H0)	at 24 hour after tracheal extubation (H0)

Secondary Outcome Measures

Name	Time	Method
Duration of Post-Anesthesia Care Unit (PACU) stay	in the post-anesthesia care unit

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France