Status:
COMPLETED
Safety and Efficacy Study of Intravenous Lidocaine After Colorectal Surgery: LIDOREHAB
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 rec...
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 m...
Eligibility Criteria
Inclusion
- Colorectal neoplasm
- Radical surgery
- Median incision
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00236249
Start Date
May 1 2005
End Date
May 1 2007
Last Update
February 18 2011
Active Locations (1)
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1
Hôpital Saint-Antoine
Paris, France, 75012