CATCH: Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT01077752

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: continuous ropivacaine preperitoneal infusion Drug: intravenous lidocaine infusion Drug: parenteral analgesia combining acetaminophen and morphine Drug: NaCl	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

95 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Patients with continuous ropivacaine preperitoneal infusion

Drug: continuous ropivacaine preperitoneal infusion

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

Drug: parenteral analgesia combining acetaminophen and morphine

parenteral analgesia combining acetaminophen and morphine

Active Comparator: 2

Patients with intravenous lidocaine infusion

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

Placebo Comparator: 3

Patients without local anesthetics

Drug: parenteral analgesia combining acetaminophen and morphine

parenteral analgesia combining acetaminophen and morphine

Drug: NaCl

NaCl

Outcome Measures

Primary Outcome Measures

Pericicatricial hyperalgesia area [72 hours after surgery]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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