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

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ClinicalTrials.gov Identifier: NCT00915265
Recruitment Status : Recruiting
First Posted : June 8, 2009
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
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.

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

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  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : October 2009
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources


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


Primary Outcome Measures :
  1. 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 :
  1. Duration of Post-Anesthesia Care Unit (PACU) stay [ Time Frame: in the post-anesthesia care unit ]


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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

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


Contacts
Contact: Patrick Lacarin 04.73.75.11.95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick Lacarin    0473751195    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Emmanuel FUTIER, MD University Hospital, Clermont-Ferrand

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 Posted: June 8, 2009    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

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