Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia - Full Text View

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:

Drug Information available for: Morphine sulfate Lidocaine hydrochloride Acetaminophen Lidocaine Ropivacaine monohydrochloride

U.S. FDA Resources

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 ]

Estimated Enrollment:	120
Study Start Date:	February 2010
Estimated 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

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 25, 2013
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
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Acetaminophen
Morphine
Lidocaine
Ropivacaine
Anesthetics, Local

Anesthetics
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Analgesics, Opioid
Narcotics

ClinicalTrials.gov processed this record on June 13, 2013

Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia (CATCH)