Safety and Efficacy Study of Intravenous Lidocaine After Colorectal Surgery: LIDOREHAB - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00236249

Purpose

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	Intervention	Phase
Colorectal Neoplasms	Drug: Lidocaine	Phase III

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Lidocaine Continuous Intravenous Administration for Postoperative Recovery After Colorectal Surgery

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Readiness for discharge, checked twice a day

Secondary Outcome Measures:

Pain every 4 hours 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 hours forward
Clinical side effects twice a day

Estimated Enrollment:	110
Study Start Date:	May 2005
Estimated Study Completion Date:	November 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236249

Contacts

Contact: Claude Jolly, MD

+33(0)-1 49 28 23 62

claude.jolly@laposte.net

Locations

France
Hôpital Saint-Antoine	Recruiting
Paris, France, 75012
Contact: Claude Jolly, MD +33(0)-1 49 28 23 62 claude.jolly@laposte.net

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Claude Jolly, MD

Assistance Publique - Hôpitaux de Paris

More Information

Study ID Numbers:	P041008, CRC04159, PRB-05621
Study First Received:	October 10, 2005
Last Updated:	March 14, 2007
ClinicalTrials.gov Identifier:	NCT00236249
Health Authority:	France: Ministry of Health

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
Surgery
Middle age
Adult
Aged

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Lidocaine
Gastrointestinal Neoplasms

Pain
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Pain, Postoperative
Colorectal Neoplasms

Additional relevant MeSH terms:

Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Cardiovascular Agents
Anesthetics, Local
Pharmacologic Actions
Neoplasms

Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009