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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of Lidocaine Continuous Intravenous Administration for Postoperative Recovery After Colorectal Surgery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Readiness for discharge, checked twice a day [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 110
Study Start Date: May 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Hôpital Saint-Antoine
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Claude Jolly, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Myriem CARRIER, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00236249     History of Changes
Other Study ID Numbers: P041008
Study First Received: October 10, 2005
Last Updated: February 17, 2011
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

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 28, 2014