Clinical Trial: Analgetic and Anxiolytic Effect of Preoperative Pregabalin

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Asker & Baerum Hospital

Current Primary Outcome: Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm) [ Time Frame: 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.


Original Primary Outcome:

  • Anxiolytic effect (verbal rating)
  • Analgetic effect (VAS)


Current Secondary Outcome: Morphine (Opioid) Consumption Cumulated [ Time Frame: 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)


Original Secondary Outcome:

  • Mobilisation
  • Satisfaction


Information By: Asker & Baerum Hospital

Dates:
Date Received: July 17, 2006
Date Started: November 2005
Date Completion:
Last Updated: July 19, 2011
Last Verified: July 2011