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NCT Number: NCT01077752

Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia

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.

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Key information

Conditions

Pain, Postoperative Hyperalgesia Nervous System Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Departement d'Anesthesie-Reanimation, Hopital Saint-Antoine

Paris, 75012, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

continuous ropivacaine preperitoneal infusion

Drug

Bolus of 20 mg after the surgery then 20 mg per hour during 48 hours

intravenous lidocaine infusion

Drug

Bolus of 60 mg after the surgery then 60 mg per hour during 48 hours

parenteral analgesia combining acetaminophen and morphine

Drug

parenteral analgesia combining acetaminophen and morphine

NaCl

Drug

NaCl

Primary outcomes

  1. Pericicatricial hyperalgesia area

    Time frame: 72 hours after surgery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Effect of Local Anesthetic Continuous Preperitoneal Wound Infiltration on Incisional Hyperalgesia Following Colorectal Laparoscopic Surgery

Acronym: CATCH

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Mar 1, 2010
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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