Phase 4
N=50
Analgetic and Anxiolytic Effect of Preoperative Pregabalin
Intervertebral Disk Displacement · Disk Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT00353704 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm) — 11.7; 22.5 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- pregabalin (Drug); Placebo (Drug); morphine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Asker & Baerum Hospital
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm) |
11.7; 22.5 | — |
| SECONDARY Morphine (Opioid) Consumption Cumulated |
7.3; 16.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of disc prolapse
- Age 18+
- ASA (American Association in Anesthesiology) I-III
- written consent
Exclusion Criteria
- Age III
- liver failure
- renal failure
- allergic reaction against gabapentin and/or pregabalin
- pregnancy
Data sourced from ClinicalTrials.gov (NCT00353704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.