Safety and Efficacy Study of Intravenous Lidocaine After Colorectal Surgery: LIDOREHAB

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00236249
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : February 18, 2011
Information provided by:
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The purpose of this study is to check if lidocaine intravenous administration during surgery and 24 hours after surgery, associated with standardised management of the patient, helps to accelerate recovery and to improve the quality of recovery, after surgery for colic or rectal neoplasms.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Lidocaine Phase 3

Detailed Description:

One of the purposes of postoperative care is to shorten the duration of recovery, in order to reduce the complications and to improve the quality of life. After abdominal surgery, two factors can be modified: early mobilisation, thanks to optimal pain control, and return to a normal feeding, permitted by transit recovery. Opioids, which are usually used for pain control, delay the intestinal transit and can be responsible for side effects like drowsiness, nausea, urine retention.

Lidocaine is a local anaesthetic, which means that it can stop the pain if it is administrated around the nerves. It can also be used intravenously. In this way, it is supposed to decrease opioid consumption, accelerate intestinal transit and even decrease inflammation. Side effects of lidocaine appear at higher plasma concentrations than those considered in the study.

After randomisation, the patient will receive either intravenous lidocaine during the surgery and 24 hours after the surgery, or physiological serum (like placebo). Every patient will dispose of patient-controlled-analgesia with morphine and of a standardised care management. Data will be collected concerning pain level, morphine consumption, psychomotor performances, duration of ileus, speed of activity recovery, quality of recovery, and side effects. Biological evaluation of lidocaine concentration and inflammation will also be done.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Lidocaine Continuous Intravenous Administration for Postoperative Recovery After Colorectal Surgery
Study Start Date : May 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Readiness for discharge, checked twice a day

Secondary Outcome Measures :
  1. Pain every 4 hours the first day after surgery, then twice a day
  2. Morphine consumption: dose of titration, then twice a day
  3. Time of transit recovery
  4. Physical rehabilitation score daily
  5. Psychomotor test daily until reaching of preoperative values
  6. Quality of recovery score at 1st, 3rd, and 6th day
  7. Satisfaction score at discharge
  8. Biological inflammation the day before the surgery, then at 1st, 3rd, and 6th day
  9. Lidocaine concentration at the end of surgery and 24 hours forward
  10. Clinical side effects twice a day

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Colorectal neoplasm
  • Radical surgery
  • Median incision

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) score equal to or up to 3
  • Unwilling or unable to use patient-controlled analgesia (PCA)
  • Chronic consumption of opioids
  • Chronic drug or alcohol abuse
  • Chronic pain
  • Unable to read or write text
  • Inflammatory disease of intestinal tract
  • Allergy to morphine
  • Allergy to lidocaine
  • Severe atrioventricular conduction dysfunction without stimulator
  • Porphyry
  • Uncontrolled epilepsy
  • History of malign hyperthermia
  • Severe cardiac failure
  • Hepatic failure
  • Myasthenia
  • Treatment with beta blockers, antiarrhythmic calcium blockers, sultopride, nonselective monoamine oxidase inhibitor (MAOI)
  • Locoregional anaesthesia planned
  • Associated surgery concerning liver, pancreas, or gall bladder
  • Laparoscopic surgery
  • Severe psychiatric pathology
  • Refusal of the patient

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 identifier (NCT number): NCT00236249

Hôpital Saint-Antoine
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Claude Jolly, MD Assistance Publique - Hôpitaux de Paris

Responsible Party: Myriem CARRIER, Department of Clinical Research of developpement Identifier: NCT00236249     History of Changes
Other Study ID Numbers: P041008
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: February 18, 2011
Last Verified: March 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Double blind method
Prospective study
Lidocaine/administration and dosage/therapeutic use
Anaesthetics local/administration and dosage
Opioids/administration and dosage
Pain, postoperative
Perioperative care
Postoperative care
Analgesia, Patient-controlled
Length of stay
Survival analysis
Patient satisfaction
Middle age

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anesthetics, Local
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