Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Active	18 to 75	Other	P041008 CRC04159, PRB-05621, NCT00236249

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Assistance Publique Hopitaux de Paris

Claude Jolly, MD

Principal Investigator

Claude Jolly, MD		Ph: +33(0)-1 49 28 23 62
		Email: claude.jolly@laposte.net

France
	Paris
	Hopital Saint Antoine
		Claude Jolly, MD	Ph: +33(0)-1 49 28 23 62
			Email: claude.jolly@laposte.net

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00236249
Information obtained from ClinicalTrials.gov on March 18, 2009