Safety and Efficacy Study of Intravenous Lidocaine After Colorectal Surgery: LIDOREHAB
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|ClinicalTrials.gov Identifier: NCT00236249|
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : February 18, 2011
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Drug: Lidocaine||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Evaluation of Lidocaine Continuous Intravenous Administration for Postoperative Recovery After Colorectal Surgery|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
- Readiness for discharge, checked twice a day
- Pain every 4 hours the first day after surgery, then twice a day
- Morphine consumption: dose of titration, then twice a day
- Time of transit recovery
- Physical rehabilitation score daily
- Psychomotor test daily until reaching of preoperative values
- Quality of recovery score at 1st, 3rd, and 6th day
- Satisfaction score at discharge
- Biological inflammation the day before the surgery, then at 1st, 3rd, and 6th day
- Lidocaine concentration at the end of surgery and 24 hours forward
- Clinical side effects twice a day
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236249
|Paris, France, 75012|
|Principal Investigator:||Claude Jolly, MD||Assistance Publique - Hôpitaux de Paris|