Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia (CATCH)

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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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

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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT01077752 History of Changes
Other Study ID Numbers:	AOR 08028
First Posted:	March 1, 2010
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:

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