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Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia (CATCH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01077752
First received: February 26, 2010
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Local Anesthetic Continuous Preperitoneal Wound Infiltration on Incisional Hyperalgesia Following Colorectal Laparoscopic Surgery

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Pericicatricial hyperalgesia area [ Time Frame: 72 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain intensity (rest/mobilization and long-term) [ Time Frame: 72 hours, 3 months and 6 months after surgery ] [ Designated as safety issue: No ]
  • Morphine consumption [ Time Frame: During 5 days after surgery ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: February 2010
Study Completion Date: February 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: continuous ropivacaine preperitoneal infusion
Drug: parenteral analgesia combining acetaminophen and morphine
parenteral analgesia combining acetaminophen and morphine
Other Name: 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
Other Name: intravenous lidocaine infusion
Drug: parenteral analgesia combining acetaminophen and morphine
parenteral analgesia combining acetaminophen and morphine
Other Name: 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
Other Name: parenteral analgesia combining acetaminophen and morphine
Drug: NaCl
NaCl
Other Name: NaCl

Detailed Description:

Besides hyperalgesia assessment, immediate postoperative and long-term pain, morphine consumption, and endocrin-metabolic response will be evaluated in this study.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077752

Locations
France
Departement d'Anesthesie-Reanimation, Hopital Saint-Antoine
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Marc Beaussier, MD PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01077752     History of Changes
Other Study ID Numbers: AOR 08028
Study First Received: February 26, 2010
Last Updated: January 20, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

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:
Hyperalgesia
Pain, Postoperative
Nervous System Diseases
Neurologic Manifestations
Pain
Pathologic Processes
Postoperative Complications
Sensation Disorders
Signs and Symptoms
Somatosensory Disorders
Acetaminophen
Anesthetics
Anesthetics, Local
Lidocaine
Morphine
Ropivacaine
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Anti-Arrhythmia Agents
Antipyretics
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014