Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients After Hip Operations

Study Overview
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Brief Summary
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Patients scheduled for primary total hip replacement needs postoperative pain treatment: i.e. morphine. Unfortunately morphine has side-effects: nausea, vomiting, sedation and dizziness, which is 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 and improve the patients pain score after operation.

Detailed Description
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We investigate the effect of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone on pain and morphine usage in the first 24 hours postoperatively in patients getting a new hip alloplastic.

Official Title
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Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for a Primary Total Hip Replacement

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Pregabalin
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for primary total hip replacement in spinal anaesthesia between the age of 55 and 75, ASA 1-3, and with BMI between 18 and 35. Exclusion Criteria: are unable to cooperate; does not speak Danish; has allergy for drugs used in the trial; has drug and/or medicine abuse; epilepsy; diabetes treated with medicine; treatment with systemic steroids within 4 weeks prior to the operation; daily use of antacids; daily use of analgesics except for NSAID, Cox2 inhibitors and Paracetamol; known kidney disease; use of antidepressants

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pregabalin|nan|
|Drug: Dexamethasone|nan|

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 0-4 h, and 0-24 h, administered by a patient controlled pain treatment. (PCA) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score (VAS) at rest and at mobilisation. |  |  | 
| Postoperative nausea and vomiting. |  |  | 
| Sedation. |  |  | 
| Dizziness |  |  | 
| All measurements are taken at 2,4 and 24 h postoperatively |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total hip replacement, Pregablin, Dexamethasone, Multimodal postoperative analgesia.