Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia (CATCH)
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
continuous ropivacaine preperitoneal infusion
intravenous lidocaine infusion
parenteral analgesia combining acetaminophen and morphine
NaCl
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Pain, postoperative, Local infiltration, Hyperalgesia, postoperative, Local anesthetic, ropivacaine, lidocaine, Colorectal laparoscopic surgery, Pain management after colorectal laparoscopic surgery
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
Sites / Locations
- Departement d'Anesthesie-Reanimation, Hopital Saint-Antoine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
1
2
3
Arm Description
Patients with continuous ropivacaine preperitoneal infusion
Patients with intravenous lidocaine infusion
Patients without local anesthetics
Outcomes
Primary Outcome Measures
Pericicatricial hyperalgesia area
Secondary Outcome Measures
Pain intensity (rest/mobilization and long-term)
Morphine consumption
Full Information
NCT ID
NCT01077752
First Posted
February 26, 2010
Last Updated
January 20, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01077752
Brief Title
Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia
Acronym
CATCH
Official Title
Effect of Local Anesthetic Continuous Preperitoneal Wound Infiltration on Incisional Hyperalgesia Following Colorectal Laparoscopic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. 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.
Detailed Description
Besides hyperalgesia assessment, immediate postoperative and long-term pain, morphine consumption, and endocrin-metabolic response will be evaluated in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Pain, postoperative, Local infiltration, Hyperalgesia, postoperative, Local anesthetic, ropivacaine, lidocaine, Colorectal laparoscopic surgery, Pain management after colorectal laparoscopic surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients with continuous ropivacaine preperitoneal infusion
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients with intravenous lidocaine infusion
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Patients without local anesthetics
Intervention Type
Drug
Intervention Name(s)
continuous ropivacaine preperitoneal infusion
Intervention Description
Bolus of 20 mg after the surgery then 20 mg per hour during 48 hours
Intervention Type
Drug
Intervention Name(s)
intravenous lidocaine infusion
Intervention Description
Bolus of 60 mg after the surgery then 60 mg per hour during 48 hours
Intervention Type
Drug
Intervention Name(s)
parenteral analgesia combining acetaminophen and morphine
Intervention Description
parenteral analgesia combining acetaminophen and morphine
Intervention Type
Drug
Intervention Name(s)
NaCl
Intervention Description
NaCl
Primary Outcome Measure Information:
Title
Pericicatricial hyperalgesia area
Time Frame
72 hours after surgery
Secondary Outcome Measure Information:
Title
Pain intensity (rest/mobilization and long-term)
Time Frame
72 hours, 3 months and 6 months after surgery
Title
Morphine consumption
Time Frame
During 5 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Beaussier, MD PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement d'Anesthesie-Reanimation, Hopital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
12. IPD Sharing Statement
Learn more about this trial
Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia
We'll reach out to this number within 24 hrs