Analgetic and Anxiolytic Effect of Preoperative Pregabalin

Phase 4

Completed

• Conditions: Intervertebral Disk Displacement; Disk Prolapse
• Interventions: Drug: Placebo; Drug: pregabalin; Drug: morphine

• Registration Number: NCT00353704
• Lead Sponsor: Asker & Baerum Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-07-17
• Study First Submitted QC: 2006-07-18
• Study First Posted: 2006-07-19
• Primary Completion: 2009-05
• Study Completion: 2010-06
• Results First Submitted: 2011-05-24
• Status Verified: 2011-07
• Results First Submitted QC: 2011-07-19
• Last Update Submitted: 2011-07-19
• Results First Posted: 2011-07-20
• Last Update Posted: 2011-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Clinical diagnosis of disc prolapse
• Age 18+
• ASA (American Association in Anesthesiology) I-III
• written consent

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Exclusion Criteria

• Age < 18
• ASA > III
• liver failure
• renal failure
• allergic reaction against gabapentin and/or pregabalin
• pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	One capsule of saccharose (placebo) was administered orally about one hour before surgery.
Placebo	morphine	One capsule of saccharose (placebo) was administered orally about one hour before surgery.
Pregabalin	pregabalin	150 mg Pregabalin per orally about one hour before surgery
Pregabalin	morphine	150 mg Pregabalin per orally about one hour before surgery

Primary Outcome Measures

Name	Time	Method
Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)	120 minutes after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Morphine (Opioid) Consumption Cumulated	240 minutes	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)

Trial Locations

Locations (1)

Asker and Baerum Hospital; 🇳🇴 Rud, Norway