Analgetic and Anxiolytic Effect of Preoperative Pregabalin
Information source: Asker & Baerum Hospital
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intervertebral Disk Displacement; Disk Prolapse
Intervention: pregabalin (Drug); Placebo (Drug); morphine (Drug)
Phase: Phase 4
Sponsored by: Asker & Baerum Hospital
Official(s) and/or principal investigator(s):
Ulrich J Spreng, Dr. med., Principal Investigator, Affiliation: Asker and Baerum Hospital, Norway
Vegard Dahl, Dr. med., Study Director, Affiliation: Asker and Baerum Hospital, Norway
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.
Official title: Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)
Secondary outcome: Morphine (Opioid) Consumption Cumulated
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
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.
Minimum age: 18 Years.
Maximum age: N/A.
- Clinical diagnosis of disc prolapse
- Age 18+
- ASA (American Association in Anesthesiology) I-III
- written consent
- Age < 18
- ASA > III
- liver failure
- renal failure
- allergic reaction against gabapentin and/or pregabalin
Locations and Contacts
Asker and Baerum Hospital, Rud 1309, Norway
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.
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.
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.
Starting date: November 2005
Last updated: July 19, 2011