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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00236249

Collaborator

(none)

110

Enrollment

Location

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 1, 2005

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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