search
Back to results

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
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
February 26, 2010
Last Updated
January 20, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
search

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