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Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine

NCT ID: NCT01439399

Last Updated: 2011-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-07-31

Brief Summary

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The aim of the present study is to evaluate the analgesic benefit of intravenous lidocaine and ketamine in the perioperative period of abdominal surgery.

Detailed Description

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Optimal postoperative pain management facilitates rehabilitation immediately after abdominal surgery. Multiple studies have demonstrated that successful postoperative analgesia also reduces perioperative complications and improves patient comfort, thereby providing many benefits for the patient. In acute postoperative pain management intravenous lidocaine and/or ketamine have been advocated because of their morphine-sparing effect.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine

Intravenous lidocaine administered preoperatively (anesthesia induction) and postoperatively during 48 hours

Group Type ACTIVE_COMPARATOR

Lidocaine,

Intervention Type DRUG

Lidocaine group received an IV bolus of 1.5 mg.kg-1 followed by a continuous infusion of 2 mg.kg-1.h-1 intraoperative and 1.33 mg.kg-1.h-1 for 48 h postoperative.

Ketamine

Intravenous ketamine administered preoperatively (anesthesia induction) and postoperatively during 48 hours

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

Ketamine group received a bolus of 0.5 mg.kg-1, then 0.25 mg.kg-1.h-1 followed by 0.1 mg.kg-1.h-1 for the first 24 h, then 0.05 mg.kg-1.h-1 for the next 24 h.

Ketamine-Lidocaine

Intravenous association of ketamine and lidocaine administered preoperatively (at anesthesia induction) and postoperatively during 48 hours.

Group Type ACTIVE_COMPARATOR

association ketamine-lidocaine

Intervention Type DRUG

Ketamine-lidocaine group received a bolus of 1.5 mg.kg-1 of lidocaine and 0.5 mg.kg-1 of ketamine, a continuous infusion of 1.3 mg.kg-1.h-1 of lidocaine and 0.17 mg.kg-1.h-1 of ketamine was delivered followed by 0.9 mg.kg-1 of lidocaine with 0.08 mg.kg-1.h-1 of ketamine during 48 h, the dose of ketamine being reduced to 0.04 mg.kg-1.h-1 after the first 24 hours.

Saline 0,9%

Control group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The control group (C) received an equal volume of saline 0.9 % during 48 h.

Interventions

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Lidocaine,

Lidocaine group received an IV bolus of 1.5 mg.kg-1 followed by a continuous infusion of 2 mg.kg-1.h-1 intraoperative and 1.33 mg.kg-1.h-1 for 48 h postoperative.

Intervention Type DRUG

Ketamine

Ketamine group received a bolus of 0.5 mg.kg-1, then 0.25 mg.kg-1.h-1 followed by 0.1 mg.kg-1.h-1 for the first 24 h, then 0.05 mg.kg-1.h-1 for the next 24 h.

Intervention Type DRUG

association ketamine-lidocaine

Ketamine-lidocaine group received a bolus of 1.5 mg.kg-1 of lidocaine and 0.5 mg.kg-1 of ketamine, a continuous infusion of 1.3 mg.kg-1.h-1 of lidocaine and 0.17 mg.kg-1.h-1 of ketamine was delivered followed by 0.9 mg.kg-1 of lidocaine with 0.08 mg.kg-1.h-1 of ketamine during 48 h, the dose of ketamine being reduced to 0.04 mg.kg-1.h-1 after the first 24 hours.

Intervention Type DRUG

Placebo

The control group (C) received an equal volume of saline 0.9 % during 48 h.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* abdominal surgery by laparotomy

Exclusion Criteria

* laparoscopy
* history of chronic pain
* opioid self-administration
* psychiatric disorders
* difficulties with communication
* renal or hepatic dysfunction
* ASA physical status \> 3
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lausanne Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Joray Florence

Chief Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Kern

Role: STUDY_DIRECTOR

University of Lausanne Hospitals

Locations

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University Hospital Center and University

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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179/05

Identifier Type: OTHER

Identifier Source: secondary_id

KL-48h

Identifier Type: -

Identifier Source: org_study_id