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Safety and Efficacy Study of Intravenous Lidocaine After Colorectal Surgery: LIDOREHAB

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Double blind method, Prospective study, Lidocaine/administration and dosage/therapeutic use, Anaesthetics local/administration and dosage, Opioids/administration and dosage, Pain, postoperative, Perioperative care, Postoperative care, Analgesia, Patient-controlled, Length of stay, Survival analysis, Patient satisfaction, Surgery, Middle age, Adult, Aged

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Saint-Antoine

Outcomes

Primary Outcome Measures

Readiness for discharge, checked twice a day

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2005
Last Updated
February 17, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00236249
Brief Title
Safety and Efficacy Study of Intravenous Lidocaine After Colorectal Surgery: LIDOREHAB
Official Title
Evaluation of Lidocaine Continuous Intravenous Administration for Postoperative Recovery After Colorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Double blind method, Prospective study, Lidocaine/administration and dosage/therapeutic use, Anaesthetics local/administration and dosage, Opioids/administration and dosage, Pain, postoperative, Perioperative care, Postoperative care, Analgesia, Patient-controlled, Length of stay, Survival analysis, Patient satisfaction, Surgery, Middle age, Adult, Aged

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lidocaine
Primary Outcome Measure Information:
Title
Readiness for discharge, checked twice a day
Secondary Outcome Measure Information:
Title
Pain every 4 hours the first day after surgery, then twice a day
Title
Morphine consumption: dose of titration, then twice a day
Title
Time of transit recovery
Title
Physical rehabilitation score daily
Title
Psychomotor test daily until reaching of preoperative values
Title
Quality of recovery score at 1st, 3rd, and 6th day
Title
Satisfaction score at discharge
Title
Biological inflammation the day before the surgery, then at 1st, 3rd, and 6th day
Title
Lidocaine concentration at the end of surgery and 24 hours forward
Title
Clinical side effects twice a day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Jolly, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France

12. IPD Sharing Statement

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Safety and Efficacy Study of Intravenous Lidocaine After Colorectal Surgery: LIDOREHAB

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