Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: continuous ropivacaine preperitoneal infusion Drug: intravenous lidocaine infusion Drug: parenteral analgesia combining acetaminophen and morphine Drug: NaCl Phase 3

Detailed Description:
Besides hyperalgesia assessment, immediate postoperative and long-term pain, morphine consumption, and endocrin-metabolic response will be evaluated in this study.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Local Anesthetic Continuous Preperitoneal Wound Infiltration on Incisional Hyperalgesia Following Colorectal Laparoscopic Surgery
Study Start Date : February 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : February 2013
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1
Patients with continuous ropivacaine preperitoneal infusion
 Drug: continuous ropivacaine preperitoneal infusion
Bolus of 20 mg after the surgery then 20 mg per hour during 48 hours

Drug: parenteral analgesia combining acetaminophen and morphine
parenteral analgesia combining acetaminophen and morphine
Active Comparator: 2
Patients with intravenous lidocaine infusion
 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
Placebo Comparator: 3
Patients without local anesthetics
 Drug: parenteral analgesia combining acetaminophen and morphine
parenteral analgesia combining acetaminophen and morphine

Drug: NaCl
NaCl


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Pericicatricial hyperalgesia area [ Time Frame: 72 hours after surgery ]

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077752


Locations
Layout table for location information
France
Departement d'Anesthesie-Reanimation, Hopital Saint-Antoine
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Marc Beaussier, MD PhD Assistance Publique - Hôpitaux de Paris
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01077752    
Other Study ID Numbers: AOR 08028
First Posted: March 1, 2010    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pain, postoperative
Local infiltration
Hyperalgesia, postoperative
 Local anesthetic, ropivacaine, lidocaine
Colorectal laparoscopic surgery
Pain management after colorectal laparoscopic surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperalgesia
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Somatosensory Disorders
Sensation Disorders
Nervous System Diseases
Acetaminophen
Lidocaine
Morphine
Ropivacaine
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Analgesics, Non-Narcotic
Antipyretics