Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna
Overview
- Phase
- Phase 4
- Intervention
- pregabalin
- Conditions
- Intervertebral Disk Displacement
- Sponsor
- Asker & Baerum Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of disc prolapse
- •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
Arms & Interventions
Pregabalin
150 mg Pregabalin per orally about one hour before surgery
Intervention: pregabalin
Pregabalin
150 mg Pregabalin per orally about one hour before surgery
Intervention: morphine
Placebo
One capsule of saccharose (placebo) was administered orally about one hour before surgery.
Intervention: Placebo
Placebo
One capsule of saccharose (placebo) was administered orally about one hour before surgery.
Intervention: morphine
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Morphine (Opioid) Consumption Cumulated(240 minutes)