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

Ketamine

Brief Summary

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.

Intervention / Treatment

  • Gabapentin + dexamethasone + ketamine (DRUG)
    Comparing analgesic effect of gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15 mg/kg
  • Placebo (DRUG)
    Matching placebo

Condition or Disease

  • Pain, Postoperative

Phase

Study Design

Study type: INTERVENTIONAL
Status: Terminated
Study results: No Results Available
Age: 55 Years to 85 Years
Enrollment: 48 (ACTUAL)
Funded by: Other
Allocation: Randomized
Primary Purpose: Treatment

Masking

Clinical Trial Dates

Start date: Oct 01, 2005
Primary Completion: Apr 01, 2008 ACTUAL
Completion Date: May 01, 2008 ACTUAL
Study First Posted: Oct 12, 2005 ESTIMATED
Results First Posted: Aug 31, 2020
Last Updated: May 14, 2008

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

Glostrup, Denmark
Herning, Denmark

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.

Eligibility Criteria

Sex: All
Minimum Age: 55
Maximum Age: 85
Healthy Volunteers: Yes

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.

Primary Outcomes
  • The total amount of morphine needed postoperatively from 0-4h; and 0-24h, administered by a patient controlled pain treatment.(PCA) 0-24h
Secondary Outcomes
  • Pain score (VAS)= at rest and at mobilisation. 0-24h
  • Postoperative Nausea and vomiting. 0-24h
  • Dizziness 0-24h
  • Sedation 0-24h
  • Nightmare and hallucinations. 0-24h
  • All measurements are taken at 2,4 and 24 h postoperatively. 0-24h

More Details

NCT Number: NCT00236223
Other IDs: SM2-05
Study URL: https://clinicaltrials.gov/study/NCT00236223
Last updated: Sep 29, 2023