Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia

Assistance Publique - Hôpitaux de Paris95 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pain, Postoperative

Interventions

continuous ropivacaine preperitoneal infusionDRUG

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

intravenous lidocaine infusionDRUG

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

parenteral analgesia combining acetaminophen and morphineDRUG

parenteral analgesia combining acetaminophen and morphine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Departement d'Anesthesie-Reanimation, Hopital Saint-Antoine

Paris, France

Outcomes

Primary Outcomes

Pericicatricial hyperalgesia area

Time frame: 72 hours after surgery

Secondary Outcomes

Pain intensity (rest/mobilization and long-term)

Time frame: 72 hours, 3 months and 6 months after surgery

Morphine consumption

Time frame: During 5 days after surgery

Data from ClinicalTrials.gov

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