Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia (CATCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01077752
Recruitment Status : Completed
First Posted : March 1, 2010
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE February 26, 2010
First Posted Date  ICMJE March 1, 2010
Last Update Posted Date January 22, 2014
Study Start Date  ICMJE February 2010
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2010)
Pericicatricial hyperalgesia area [ Time Frame: 72 hours after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2014)
95
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2010)
120
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01077752
Other Study ID Numbers  ICMJE AOR 08028
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc Beaussier, MD PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP