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Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Lidocaine,
Ketamine
association ketamine-lidocaine
Placebo
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring postoperative pain, postoperative care, intravenous lidocaine, intravenous ketamine, morphine consumption

Eligibility Criteria

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

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

Sites / Locations

  • University Hospital Center and University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Lidocaine

Ketamine

Ketamine-Lidocaine

Saline 0,9%

Arm Description

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

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

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

Control group

Outcomes

Primary Outcome Measures

Cumulative morphine consumption
Cumulative morphine consumption over 48 hours postoperatively

Secondary Outcome Measures

Pain scores
Pain scores at rest and movement
Mechanical hyperalgesia
Mechanical hyperalgesia using pressure algometry
Occurrence of side effects
Occurrence of side effects: sedation, nausea, vomiting, itching, nightmares

Full Information

First Posted
September 20, 2011
Last Updated
September 21, 2011
Sponsor
University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT01439399
Brief Title
Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine
Official Title
Analgesic Efficacy of Intravenous Perfusion of Lidocaine, Ketamine or a Combination After Laparotomy in a Placebo-controlled, Randomized, Double-blind Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
postoperative pain, postoperative care, intravenous lidocaine, intravenous ketamine, morphine consumption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Intravenous lidocaine administered preoperatively (anesthesia induction) and postoperatively during 48 hours
Arm Title
Ketamine
Arm Type
Active Comparator
Arm Description
Intravenous ketamine administered preoperatively (anesthesia induction) and postoperatively during 48 hours
Arm Title
Ketamine-Lidocaine
Arm Type
Active Comparator
Arm Description
Intravenous association of ketamine and lidocaine administered preoperatively (at anesthesia induction) and postoperatively during 48 hours.
Arm Title
Saline 0,9%
Arm Type
Placebo Comparator
Arm Description
Control group
Intervention Type
Drug
Intervention Name(s)
Lidocaine,
Intervention Description
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
Intervention Name(s)
Ketamine
Intervention Description
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
Intervention Name(s)
association ketamine-lidocaine
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
The control group (C) received an equal volume of saline 0.9 % during 48 h.
Primary Outcome Measure Information:
Title
Cumulative morphine consumption
Description
Cumulative morphine consumption over 48 hours postoperatively
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Pain scores
Description
Pain scores at rest and movement
Time Frame
48 hours
Title
Mechanical hyperalgesia
Description
Mechanical hyperalgesia using pressure algometry
Time Frame
48 hours
Title
Occurrence of side effects
Description
Occurrence of side effects: sedation, nausea, vomiting, itching, nightmares
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Kern
Organizational Affiliation
University of Lausanne Hospitals
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Center and University
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
CH-1011
Country
Switzerland

12. IPD Sharing Statement

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Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine

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