Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236249
Status:
COMPLETED
Last Update Posted:
2011-02-18
First Post:
2005-10-10
Brief Title:
Safety and Efficacy Study of Intravenous Lidocaine After Colorectal Surgery LIDOREHAB
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Evaluation of Lidocaine Continuous Intravenous Administration for Postoperative Recovery After Colorectal Surgery
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None