Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia

Pain, Postoperative Clinical Trial

— CATCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077752
• Other study ID #: AOR 08028
• Status: Completed
• Phase: Phase 3
• First received: February 26, 2010
• Last updated: January 20, 2014
• Start date: February 2010
• Est. completion date: February 2013

Study information

• Verified date: January 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: February 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperalgesia
• Pain, Postoperative

Intervention

Drug:
• continuous ropivacaine preperitoneal infusion
Bolus of 20 mg after the surgery then 20 mg per hour during 48 hours
• intravenous lidocaine infusion
Bolus of 60 mg after the surgery then 60 mg per hour during 48 hours
• parenteral analgesia combining acetaminophen and morphine
parenteral analgesia combining acetaminophen and morphine
• NaCl
NaCl

Locations

Country	Name	City	State
France	Departement d'Anesthesie-Reanimation, Hopital Saint-Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pericicatricial hyperalgesia area		72 hours after surgery	No
Secondary	Pain intensity (rest/mobilization and long-term)		72 hours, 3 months and 6 months after surgery	No
Secondary	Morphine consumption		During 5 days after surgery	No