Clinical trial NCT00236249: Safety and Efficacy Study of Intravenous Lidocaine After Colorectal Surgery: LIDOREHAB
Official title: Evaluation of Lidocaine Continuous Intravenous Administration for Postoperative Recovery After Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Neoplasms
Keywords: 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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-10-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Readiness for discharge, checked twice a day
Secondary outcomes:
measure: Pain every 4 hours the first day after surgery, then twice a day
measure: Morphine consumption: dose of titration, then twice a day
measure: Time of transit recovery
measure: Physical rehabilitation score daily
measure: Psychomotor test daily until reaching of preoperative values
measure: Quality of recovery score at 1st, 3rd, and 6th day
measure: Satisfaction score at discharge
measure: Biological inflammation the day before the surgery, then at 1st, 3rd, and 6th day
measure: Lidocaine concentration at the end of surgery and 24 hours forward
measure: Clinical side effects twice a day
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint-Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Claude Jolly, MD
role: PRINCIPAL_INVESTIGATOR
References: