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Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia (CATCH)

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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
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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
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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
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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
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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
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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
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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
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France
Departement d'Anesthesie-Reanimation, Hopital Saint-Antoine
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Marc Beaussier, MD PhD Assistance Publique - Hôpitaux de Paris
More Information
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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:
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Hyperalgesia
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
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