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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00236249
First received: October 10, 2005
Last updated: February 17, 2011
Last verified: March 2007
History of Changes

October 10, 2005
February 17, 2011
May 2005
May 2007   (final data collection date for primary outcome measure)
Readiness for discharge, checked twice a day [ Designated as safety issue: Yes ]
Readiness for discharge, checked twice a day
Complete list of historical versions of study NCT00236249 on ClinicalTrials.gov Archive Site
  • Pain every 4 hours the first day after surgery, then twice a day [ Designated as safety issue: Yes ]
  • Morphine consumption: dose of titration, then twice a day [ Designated as safety issue: Yes ]
  • Time of transit recovery [ Designated as safety issue: Yes ]
  • Physical rehabilitation score daily [ Designated as safety issue: Yes ]
  • Psychomotor test daily until reaching of preoperative values [ Designated as safety issue: Yes ]
  • Quality of recovery score at 1st, 3rd, and 6th day [ Designated as safety issue: Yes ]
  • Satisfaction score at discharge [ Designated as safety issue: Yes ]
  • Biological inflammation the day before the surgery, then at 1st, 3rd, and 6th day [ Designated as safety issue: Yes ]
  • Lidocaine concentration at the end of surgery and 24 hours forward [ Designated as safety issue: Yes ]
  • Clinical side effects twice a day [ Designated as safety issue: Yes ]
  • Pain every 4 h the first day after surgery, then twice a day
  • Morphine consumption: dose of titration, then twice a day
  • Time of transit recovery
  • Physical rehabilitation score daily
  • Psychomotor test daily until reaching of preoperative values
  • Quality of recovery score at 1st, 3rd, and 6th day
  • Satisfaction score at discharge
  • Biological inflammation the day before the surgery, then at 1st, 3rd, and 6th day,
  • Lidocaine concentration at the end of surgery and 24 h forward,
  • Clinical side effects twice a day
Not Provided
Not Provided
 
Safety and Efficacy Study of Intravenous Lidocaine After Colorectal Surgery: LIDOREHAB
Evaluation of Lidocaine Continuous Intravenous Administration for Postoperative Recovery After Colorectal Surgery

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Colorectal Neoplasms
Drug: Lidocaine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
May 2007
May 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00236249
P041008
Yes
Myriem CARRIER, Department of Clinical Research of developpement
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Claude Jolly, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP