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

Phase 4

Terminated

• Conditions: Pain, Postoperative
• Interventions: Drug: Gabapentin + dexamethasone + ketamine; Drug: Placebo

• Registration Number: NCT00236223
• Lead Sponsor: Glostrup University Hospital, Copenhagen

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.

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 Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-07
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-12
• Primary Completion: 2008-04
• Status Verified: 2008-05
• Study Completion: 2008-05
• Last Update Submitted: 2008-05-14
• Last Update Posted: 2008-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Gabapentin + dexamethasone + ketamine	-
2	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Operations og Anæstesiologisk afd. Y, KAS Glostrup; 🇩🇰 Glostrup, Denmark

Anæstesiafdelingen, Herning Centralsygehus; 🇩🇰 Herning, Denmark