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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00915265
First Posted: June 8, 2009
Last Update Posted: May 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
  Purpose
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.

Condition Intervention Phase
Open Colorectal Surgery Early Rehabilitation After Surgery Other: Multilobed catheter (group CPA) Other: Multilobed catheter (group EA) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Continuous Preperitoneal Versus Epidural Infusion of Local Anesthetic for Enhanced Postoperative Recovery Following Open Colorectal Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • Duration of Post-Anesthesia Care Unit (PACU) stay [ Time Frame: in the post-anesthesia care unit ]

Enrollment: 100
Study Start Date: October 2009
Study Completion Date: May 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Multilobed catheter (group CPA)
    - 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
    Other: Multilobed catheter (group EA)
    EA group : thoracic epidural infusion of 0.2 % ropivacaine
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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915265


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Emmanuel FUTIER, MD University Hospital, Clermont-Ferrand
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00915265     History of Changes
Other Study ID Numbers: CHU-0052
First Submitted: June 5, 2009
First Posted: June 8, 2009
Last Update Posted: May 16, 2012
Last Verified: May 2012

Keywords provided by University Hospital, Clermont-Ferrand:
Epidural analgesia
Continuous preperitoneal analgesia
Surgery
Open colorectal surgery
Fast-track surgery
ERAS

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents