Intervertebral Disk Displacement Clinical Trial
Official title:
Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna
Verified date | July 2011 |
Source | Asker & Baerum Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Norway: Norwegian Medicines Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2010 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of disc prolapse - Age 18+ - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Asker and Baerum Hospital | Rud |
Lead Sponsor | Collaborator |
---|---|
Asker & Baerum Hospital |
Norway,
Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Anesthesiology. 2002 Sep;97(3):560-4. — View Citation
Ménigaux C, Adam F, Guignard B, Sessler DI, Chauvin M. Preoperative gabapentin decreases anxiety and improves early functional recovery from knee surgery. Anesth Analg. 2005 May;100(5):1394-9, table of contents. — View Citation
Woolf CJ, Chong MS. Preemptive analgesia--treating postoperative pain by preventing the establishment of central sensitization. Anesth Analg. 1993 Aug;77(2):362-79. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm) | 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. | 120 minutes after surgery | No |
Secondary | Morphine (Opioid) Consumption Cumulated | 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) | 240 minutes | No |
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