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

Glostrup University Hospital, Copenhagen

Status and phase: Terminated; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Gabapentin + dexamethasone + ketamine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00236223

SM2-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Gabapentin + dexamethasone + ketamine

2

Placebo Comparator group

Treatment:

Drug: Placebo