Safety and Efficacy Study of Intravenous Lidocaine After Colorectal Surgery: LIDOREHAB
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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 |
- Readiness for discharge, checked twice a day [ Designated as safety issue: Yes ]
- 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) |
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 |
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 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 May 19, 2013