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

January 30, 2018 updated by: University Hospital, Clermont-Ferrand

Continuous Preperitoneal Versus Epidural Infusion of Local Anesthetic for Enhanced Postoperative Recovery Following Open Colorectal Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: at 24 hour after tracheal extubation (H0)
at 24 hour after tracheal extubation (H0)

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of Post-Anesthesia Care Unit (PACU) stay
Time Frame: in the post-anesthesia care unit
in the post-anesthesia care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Emmanuel FUTIER, MD, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (Estimate)

June 8, 2009

Study Record Updates

Last Update Posted (Actual)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHU-0052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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