Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia

Phase 3

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: intravenous lidocaine infusion; Drug: continuous ropivacaine preperitoneal infusion; Drug: NaCl; Drug: parenteral analgesia combining acetaminophen and morphine

• Registration Number: NCT01077752
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-02-26
• Study First Posted: 2010-03-01
• Primary Completion: 2012-06
• Study Completion: 2013-02
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	intravenous lidocaine infusion	Patients with intravenous lidocaine infusion
3	NaCl	Patients without local anesthetics
1	continuous ropivacaine preperitoneal infusion	Patients with continuous ropivacaine preperitoneal infusion
1	parenteral analgesia combining acetaminophen and morphine	Patients with continuous ropivacaine preperitoneal infusion
2	parenteral analgesia combining acetaminophen and morphine	Patients with intravenous lidocaine infusion
3	parenteral analgesia combining acetaminophen and morphine	Patients without local anesthetics

Primary Outcome Measures

Name	Time	Method
Pericicatricial hyperalgesia area	72 hours after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Departement d'Anesthesie-Reanimation, Hopital Saint-Antoine; 🇫🇷 Paris, France