Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia (CATCH)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: intravenous lidocaine infusion; Drug: continuous ropivacaine preperitoneal infusion; Drug: parenteral analgesia combining acetaminophen and morphine; Drug: NaCl

Study type: Interventional

Funder types: Other

Identifiers

NCT01077752

AOR 08028

Details and patient eligibility

About

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.

Full description

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

Enrollment: 95 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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95 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Patients with continuous ropivacaine preperitoneal infusion

Treatment:

Drug: continuous ropivacaine preperitoneal infusion

Drug: parenteral analgesia combining acetaminophen and morphine

2

Active Comparator group

Description:

Patients with intravenous lidocaine infusion

Treatment:

Drug: parenteral analgesia combining acetaminophen and morphine

Drug: intravenous lidocaine infusion

3

Placebo Comparator group

Description:

Patients without local anesthetics

Treatment:

Drug: parenteral analgesia combining acetaminophen and morphine

Drug: NaCl