Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia

Study Overview
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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.

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.

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: continuous ropivacaine preperitoneal infusion
* Drug: intravenous lidocaine infusion
* Drug: parenteral analgesia combining acetaminophen and morphine
* Drug: NaCl


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pericicatricial hyperalgesia area |  | 72 hours after surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, postoperative, Local infiltration, Hyperalgesia, postoperative, Local anesthetic, ropivacaine, lidocaine, Colorectal laparoscopic surgery, Pain management after colorectal laparoscopic surgery