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Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia

NCT01077752 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2014-01-22

No results posted yet for this study

Summary

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.

Conditions

  • Pain, Postoperative

Interventions

DRUG

continuous ropivacaine preperitoneal infusion

Bolus of 20 mg after the surgery then 20 mg per hour during 48 hours

DRUG

intravenous lidocaine infusion

Bolus of 60 mg after the surgery then 60 mg per hour during 48 hours

DRUG

parenteral analgesia combining acetaminophen and morphine

parenteral analgesia combining acetaminophen and morphine

DRUG

NaCl

NaCl

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Marc Beaussier, MD PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-06-30
Completion
2013-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01077752 on ClinicalTrials.gov