Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Patients with continuous ropivacaine preperitoneal infusion

Group Type EXPERIMENTAL

continuous ropivacaine preperitoneal infusion

Intervention Type DRUG

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

parenteral analgesia combining acetaminophen and morphine

Intervention Type DRUG

parenteral analgesia combining acetaminophen and morphine

2

Patients with intravenous lidocaine infusion

Group Type ACTIVE_COMPARATOR

intravenous lidocaine infusion

Intervention Type DRUG

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

parenteral analgesia combining acetaminophen and morphine

Intervention Type DRUG

parenteral analgesia combining acetaminophen and morphine

3

Patients without local anesthetics

Group Type PLACEBO_COMPARATOR

parenteral analgesia combining acetaminophen and morphine

Intervention Type DRUG

parenteral analgesia combining acetaminophen and morphine

NaCl

Intervention Type DRUG

NaCl

Interventions

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continuous ropivacaine preperitoneal infusion

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

Intervention Type DRUG

intravenous lidocaine infusion

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

Intervention Type DRUG

parenteral analgesia combining acetaminophen and morphine

Intervention Type DRUG

NaCl

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No