Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Gabapentin + dexamethasone + ketamine
  • Comparing analgesic effect of gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15 mg/kg
• Drug: Placebo
  • Matching placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• Pain score (VAS)= at rest and at mobilisation.
  • Time Frame: 0-24h
    Safety Issue?: No
• Postoperative Nausea and vomiting.
  • Time Frame: 0-24h
    Safety Issue?: No
• Dizziness
  • Time Frame: 0-24h
    Safety Issue?: No
• Sedation
  • Time Frame: 0-24h
    Safety Issue?: No
• Nightmare and hallucinations.
  • Time Frame: 0-24h
    Safety Issue?: No
• All measurements are taken at 2,4 and 24 h postoperatively.
  • Time Frame: 0-24h
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Glostrup University Hospital,Copenhagen

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00236223

Study ID Number: SM2-05

ClinicalTrials.gov Identifier: NCT00236223

Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics