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

NCT00236249 | Completed Phase 3 DMC

• 1 other identifier: P041008
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Readiness for discharge, checked twice a day

Secondary Outcomes (10)

• 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

Interventions

Lidocaine DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Colorectal neoplasm
• Radical surgery
• Median incision

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint-Antoine

Paris, 75012, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Pain, Postoperative; Agnosia; Patient Satisfaction

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Claude Jolly, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 10, 2005
• First Posted: October 12, 2005
• Study Start: May 1, 2005
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: February 18, 2011

Record last verified: 2007-03

Locations

FR (1)