NCT00353704

Analgetic and Anxiolytic Effect of Preoperative Pregabalin

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Asker & Baerum Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intervertebral Disk Displacement
• Disk Prolapse

Interventions

Type	Name	Description
DRUG	pregabalin	capsule 150 mg x 1 per orally one hour before surgery
DRUG	Placebo	One capsule of saccharose (placebo) was administered about one hour before surgery
DRUG	morphine	All patients were equipped with a PCA (patient controlled analgesia) for 24 hours after surgery. The sum of morphine used was registered (milligram).

Timeline

• Start date: 2005-11-01
• Primary completion: 2009-05-01
• Completion: 2010-06-01
• First posted: 2006-07-19
• Last updated: 2011-07-20
• Results posted: 2011-07-20

Locations

1 site across 1 country: Norway