Analgetic and Anxiolytic Effect of Preoperative Pregabalin

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces the amount and degree of postoperative pain. Furthermore the purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces anxiety prior to anaesthesia in these patients.

Detailed Description
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The mechanism of development of postoperative pain is complex. Central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. Several studies have shown, that gabapentin can be effective to reduce sensitization and postoperative pain. Pregabalin (S-aminomethyl-5-methylhexaninacid) is a further development of gabapentin. Pregabalin has a fewer side-effects compared with gabapentin. The purpose of this study is to compare the analgetic and anxiolytic effect of pregabalin and placebo used as premedication. The hypothesis is that a single-dose pregabalin (150 mg postoperatively (p.o.)) gives significant better anxiolysis and analgesia than placebo. The study is including patients undergoing surgery of the vertebral columna.

Official Title
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Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna

Conditions
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Intervertebral Disk Displacement, Disk Prolapse

Intervention / Treatment
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* Drug: pregabalin
* Drug: Placebo
* Drug: morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of disc prolapse Age 18+ ASA (American Association in Anesthesiology) I-III written consent Exclusion Criteria: Age < 18 ASA > III liver failure renal failure allergic reaction against gabapentin and/or pregabalin pregnancy

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Pregabalin<br>150 mg Pregabalin per orally about one hour before surgery | Drug: pregabalin<br>* capsule 150 mg x 1 per orally one hour before surgery<br>Drug: morphine<br>* All patients were equipped with a PCA (patient controlled analgesia) for 24 hours after surgery. The sum of morphine used was registered (milligram).<br>|
| Placebo Comparator: Placebo<br>One capsule of saccharose (placebo) was administered orally about one hour before surgery. | Drug: Placebo<br>* One capsule of saccharose (placebo) was administered about one hour before surgery<br>Drug: morphine<br>* All patients were equipped with a PCA (patient controlled analgesia) for 24 hours after surgery. The sum of morphine used was registered (milligram).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm) | The visual analogue scale (VAS) was used for registration of the pain intensity at rest. The score ranges from 0-100, where 0 means no pain and 100 means maximal pain. Higher values represent a worse outcome. | 120 minutes after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine (Opioid) Consumption Cumulated | Patients were equipped with a morphine PCA (patient controlled analgesia) for 24 hours after surgery. So they could administrate morphine intravenously by pressing a button. The sum of morphine was registered as  cumulated opioid consumption (milligram) | 240 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervertebral disk displacement, disk prolapse, pregabalin