Safety and Efficacy Study of Intravenous Lidocaine After Colorectal Surgery: LIDOREHAB
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.
|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 ]
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00236249
|Paris, France, 75012|
|Principal Investigator:||Claude Jolly, MD||Assistance Publique - Hôpitaux de Paris|