Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia (CATCH)

• ClinicalTrials.gov Identifier: NCT01077752
• Recruitment Status: Completed
• First Posted: March 1, 2010
• Last Update Posted: January 22, 2014
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: February 26, 2010
• First Posted Date: March 1, 2010
• Last Update Posted Date: January 22, 2014
• Study Start Date: February 2010
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 26, 2010): Pericicatricial hyperalgesia area [ Time Frame: 72 hours after surgery ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 21, 2010)

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

Original Secondary Outcome Measures (submitted: February 26, 2010)

• Pain intensity (rest/mobilization and long-term) [ Time Frame: 72 hours, 3 months and 6 months after surgery ]
• Morphine consumption [ Time Frame: During 5 days after surgery ]
• Endocrin-metabolic response [ Time Frame: 8, 16 and 20 hours, day 1, day 2 after surgery ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia
• Official Title: Effect of Local Anesthetic Continuous Preperitoneal Wound Infiltration on Incisional Hyperalgesia Following Colorectal Laparoscopic Surgery
• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Pain, Postoperative

Intervention

• Drug: continuous ropivacaine preperitoneal infusion
  Bolus of 20 mg after the surgery then 20 mg per hour during 48 hours
• 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
• Drug: NaCl
  NaCl

Study Arms

• Experimental: 1
  Patients with continuous ropivacaine preperitoneal infusion
  Interventions:

  • Drug: continuous ropivacaine preperitoneal infusion
  • Drug: parenteral analgesia combining acetaminophen and morphine
• Active Comparator: 2
  Patients with intravenous lidocaine infusion
  Interventions:

  • Drug: intravenous lidocaine infusion
  • Drug: parenteral analgesia combining acetaminophen and morphine
• Placebo Comparator: 3
  Patients without local anesthetics
  Interventions:

  • Drug: parenteral analgesia combining acetaminophen and morphine
  • Drug: NaCl

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 20, 2014): 95
• Original Estimated Enrollment (submitted: February 26, 2010): 120
• Actual Study Completion Date: February 2013
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01077752
• Other Study ID Numbers: AOR 08028
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Assistance Publique - Hôpitaux de Paris
• Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Not Provided

Investigators

• Principal Investigator: Marc Beaussier, MD PhD; Assistance Publique - Hôpitaux de Paris

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: January 2014