Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients

Study Overview
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Brief Summary
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Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine. Unfortunately morphine has side-effect: 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.

Detailed Description
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Combinations of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone is investigated. Primary outcome is 24 hours morphine usage.

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 Abdominal Hysterectomy.

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Pregabalin; Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women scheduled for abdominal hysterectomy, between the age of 18 and 75, ASA 1-2 BMI between 18-32. Exclusion Criteria: Patients who: Are unable to cooperate Has cancer ovarian Does not speak Danish Has allergy for drugs used in the trial Has drug and medicine abuse Epilepsy Diabetes treated with medicine Chronic pain condition Daily use of antacids or analgesic Known kidney disease Use of antidepressive

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br> | Drug: Pregabalin; Dexamethasone<br>* Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg<br>|
| Experimental: B<br>Pregabalin | Drug: Pregabalin; Dexamethasone<br>* Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg<br>|
| Experimental: C<br>Pregabalin + dexamethasone | Drug: Pregabalin; Dexamethasone<br>* Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg<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 form 0 - 4 h, and 0 - 24 h, administered by the 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 | 
| Sedation. |  | 0 - 24h | 
| Dizziness. |  | 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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Pregabalin, Abdominal hysterectomy, Dexamethasone, Multimodal postoperative analgesia