|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Asker & Baerum Hospital |
| Information provided by: | Asker & Baerum Hospital |
| ClinicalTrials.gov Identifier: | NCT00353704 |
Purpose
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 is the purpose of this study to determine whether the use of oral pregabalin 150 mg as premedication reduces anxiety prior to anaesthesia in these patients.
| Condition | Intervention | Phase |
|
Intervertebral Disk Displacement Disk Prolapse |
Drug: pregabalin |
Phase IV |
| MedlinePlus related topics: | Herniated Disk |
| ChemIDplus related topics: | Pregabalin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna |
| Estimated Enrollment: | 80 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | September 2008 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
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 p.o.) gives significant better anxiolysis and analgesia than placebo.
The study is including patients undergoing surgery of the vertebral columna.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ulrich J Spreng, Dr. med. | 47-6780-9400 | ulrich.spreng@sabhf.no |
| Contact: Vegard Dahl, Dr. med. | 47-9780-9400 | vegard.dahl@sabhf.no |
| Norway | |||||
| Asker and Baerum Hospital | Recruiting | ||||
| Rud, Norway, 1309 | |||||
| Contact: Ulrich J Spreng, Dr. med. 47-6780-9400 ulrich.spreng@sabhf.no | |||||
| Asker & Baerum Hospital |
| Principal Investigator: | Ulrich J Spreng, Dr. med. | Asker and Baerum Hospital, Norway |
| Study Director: | Vegard Dahl, Dr. med. | Asker and Baerum Hospital, Norway |
More Information
| Responsible Party: | Asker and Baerum Hospital ( Ulrich Johannes Spreng ) |
| Study ID Numbers: | 2005-003229-20 |
| First Received: | July 17, 2006 |
| Last Updated: | May 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00353704 |
| Health Authority: | Norway: Norwegian Medicines Agency |
|
|
|
|
|