Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia (CATCH)

January 20, 2014 updated by: Assistance Publique - Hôpitaux de Paris

Effect of Local Anesthetic Continuous Preperitoneal Wound Infiltration on Incisional Hyperalgesia Following Colorectal Laparoscopic Surgery

In this multicenter, randomised, placebo-controlled, double-blind trial, hyperalgesia area around the scarce following colorectal laparoscopic surgery (piece removal) will be assessed in 3 groups of patients : group 1: continuous ropivacaine preperitoneal infusion, group 2 : intravenous lidocaine infusion, or group 3 : control group without local anesthetics. All patients will receive parenteral analgesia combining acetaminophen and morphine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Besides hyperalgesia assessment, immediate postoperative and long-term pain, morphine consumption, and endocrin-metabolic response will be evaluated in this study.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 3

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
      • Paris, France, 75012
        • Departement d'Anesthesie-Reanimation, Hopital Saint-Antoine

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 80
  • ASA status 1 - 3
  • Colorectal laparoscopic surgery with piece removal
  • French speaking
  • Written informed consent

Exclusion Criteria:

  • laparoscopy without colorectal extraction
  • chronic pain
  • analgesic consumption during the 24 hours previous to the surgery
  • morphine and LA intolerance
  • drug addiction
  • inflammatory bowel disease
  • general inflammatory disease
  • sepsis
  • anemia < 10 gr/dl
  • liver or renal or cardiac insufficiency
  • uncontrolled diabetes
  • preoperative consumption of opiate/corticosteroid/beta-blockers, and anti-arrhythmic drugs, MAOIs, neuroleptics.
  • preoperative consumption of NSAIDs excluding aspirin referred cardiology

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patients with continuous ropivacaine preperitoneal infusion
Drug: continuous ropivacaine preperitoneal infusion
Bolus of 20 mg after the surgery then 20 mg per hour during 48 hours
Drug: parenteral analgesia combining acetaminophen and morphine
parenteral analgesia combining acetaminophen and morphine
Active Comparator: 2
Patients with intravenous lidocaine infusion
Drug: parenteral analgesia combining acetaminophen and morphine
parenteral analgesia combining acetaminophen and morphine
Drug: intravenous lidocaine infusion
Bolus of 60 mg after the surgery then 60 mg per hour during 48 hours
Placebo Comparator: 3
Patients without local anesthetics
Drug: parenteral analgesia combining acetaminophen and morphine
parenteral analgesia combining acetaminophen and morphine
Drug: NaCl
NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pericicatricial hyperalgesia area
Time Frame: 72 hours after surgery
72 hours after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain intensity (rest/mobilization and long-term)
Time Frame: 72 hours, 3 months and 6 months after surgery
72 hours, 3 months and 6 months after surgery
Morphine consumption
Time Frame: During 5 days after surgery
During 5 days after surgery

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Marc Beaussier, MD PhD, Assistance Publique - Hôpitaux de Paris

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

February 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

February 26, 2010

First Posted (Estimate)

March 1, 2010

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 20, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOR 08028

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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