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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00236249 |
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Date of registration:
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10/10/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy Study of Intravenous Lidocaine After Colorectal Surgery: LIDOREHAB
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Scientific title:
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Evaluation of Lidocaine Continuous Intravenous Administration for Postoperative Recovery After Colorectal Surgery |
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Date of first enrolment:
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May 2005 |
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Target sample size:
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110 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00236249 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Claude Jolly, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Neoplasms
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Intervention(s)
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Drug: Lidocaine
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Primary Outcome(s)
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Readiness for discharge, checked twice a day
[Time Frame: Yes]
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Secondary Outcome(s)
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Quality of recovery score at 1st, 3rd, and 6th day
[Time Frame: Yes]
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Physical rehabilitation score daily
[Time Frame: Yes]
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Biological inflammation the day before the surgery, then at 1st, 3rd, and 6th day
[Time Frame: Yes]
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Morphine consumption: dose of titration, then twice a day
[Time Frame: Yes]
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Time of transit recovery
[Time Frame: Yes]
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Psychomotor test daily until reaching of preoperative values
[Time Frame: Yes]
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Clinical side effects twice a day
[Time Frame: Yes]
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Satisfaction score at discharge
[Time Frame: Yes]
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Lidocaine concentration at the end of surgery and 24 hours forward
[Time Frame: Yes]
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Pain every 4 hours the first day after surgery, then twice a day
[Time Frame: Yes]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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