Analgetic and Anxiolytic Effect of Preoperative Pregabalin
NCT ID: NCT00353704
Last Updated: 2011-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2005-11-30
2010-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pregabalin
150 mg Pregabalin per orally about one hour before surgery
pregabalin
capsule 150 mg x 1 per orally one hour before surgery
morphine
All patients were equipped with a PCA (patient controlled analgesia) for 24 hours after surgery. The sum of morphine used was registered (milligram).
Placebo
One capsule of saccharose (placebo) was administered orally about one hour before surgery.
Placebo
One capsule of saccharose (placebo) was administered about one hour before surgery
morphine
All patients were equipped with a PCA (patient controlled analgesia) for 24 hours after surgery. The sum of morphine used was registered (milligram).
Interventions
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pregabalin
capsule 150 mg x 1 per orally one hour before surgery
Placebo
One capsule of saccharose (placebo) was administered about one hour before surgery
morphine
All patients were equipped with a PCA (patient controlled analgesia) for 24 hours after surgery. The sum of morphine used was registered (milligram).
Eligibility Criteria
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Inclusion Criteria
* Age 18+
* ASA (American Association in Anesthesiology) I-III
* written consent
Exclusion Criteria
* ASA \> III
* liver failure
* renal failure
* allergic reaction against gabapentin and/or pregabalin
* pregnancy
18 Years
ALL
No
Sponsors
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Asker & Baerum Hospital
OTHER
Responsible Party
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Asker and Baerum Hospital
Principal Investigators
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Ulrich J Spreng, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Asker and Baerum Hospital, Norway
Vegard Dahl, Dr. med.
Role: STUDY_DIRECTOR
Asker and Baerum Hospital, Norway
Locations
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Asker and Baerum Hospital
Rud, , Norway
Countries
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References
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Woolf CJ, Chong MS. Preemptive analgesia--treating postoperative pain by preventing the establishment of central sensitization. Anesth Analg. 1993 Aug;77(2):362-79. doi: 10.1213/00000539-199377020-00026. No abstract available.
Menigaux 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):1394-1399. doi: 10.1213/01.ANE.0000152010.74739.B8.
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. doi: 10.1097/00000542-200209000-00007.
Spreng UJ, Dahl V, Raeder J. Effect of a single dose of pregabalin on post-operative pain and pre-operative anxiety in patients undergoing discectomy. Acta Anaesthesiol Scand. 2011 May;55(5):571-6. doi: 10.1111/j.1399-6576.2011.02410.x. Epub 2011 Mar 8.
Other Identifiers
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2005-003229-20
Identifier Type: -
Identifier Source: org_study_id
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