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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Gabapentin + dexamethasone + ketamine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Gabapentin + dexamethasone + ketamine<br>* Comparing analgesic effect of gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15 mg/kg<br>* Other names: Postoperative pain;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary hip replacement, Gabapentin, Dexamethasone, Ketamine, Multimodal postoperative analgesia.