The Effect of Gabapentin, Ketamine and Dexamethasone on Pain and Opioid Requirements After Hip Surgery

May 14, 2008 updated by: Glostrup University Hospital, Copenhagen

The Effect of Gabapentin, Low Dose Ketamine, Paracetamol, NSAID and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Primary Total Hip Replacement

Patients scheduled for primary hip replacement needs postoperative pain treatment, i.e. morphine. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These side-effects are unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The effect on postoperative pain of the combination of preoperative gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15mg/kg versus placebo is investigated on patients having a hip alloplastic operation.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Operations og Anæstesiologisk afd. Y, KAS Glostrup
      • Herning, Denmark, 7400
        • Anæstesiafdelingen, Herning Centralsygehus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

53 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for primary total hip replacement,
  • Between 55 and 85 years of age,
  • ASA 1-3 and BMI between 18 and 35.

Exclusion Criteria:

Patients who are:

  • Unable to cooperate
  • Does not speak Danish
  • Has allergy for drugs used in the trial
  • Drug or alcohol abuse
  • Epilepsy
  • Medically treated diabetes
  • Known kidney disease
  • Daily use of analgetics
  • Apart from NSAID
  • Paracetamol or COX2 inhibitors
  • Are treated with a antidepressive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Gabapentin + dexamethasone + ketamine
Comparing analgesic effect of gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15 mg/kg
Other Names:
  • Postoperative pain
  • Anti-hyperalgesics
Placebo Comparator: 2
Drug: Placebo
Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The total amount of morphine needed postoperatively from 0-4h; and 0-24h, administered by a patient controlled pain treatment.(PCA)
Time Frame: 0-24h
0-24h

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain score (VAS)= at rest and at mobilisation.
Time Frame: 0-24h
0-24h
Postoperative Nausea and vomiting.
Time Frame: 0-24h
0-24h
Dizziness
Time Frame: 0-24h
0-24h
Sedation
Time Frame: 0-24h
0-24h
Nightmare and hallucinations.
Time Frame: 0-24h
0-24h
All measurements are taken at 2,4 and 24 h postoperatively.
Time Frame: 0-24h
0-24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glostrup University Hospital, Copenhagen

Investigators

  • Principal Investigator: Ole Mathiesen, MD, Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

May 15, 2008

Last Update Submitted That Met QC Criteria

May 14, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM2-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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