Clinical trial NCT00353704: Analgetic and Anxiolytic Effect of Preoperative Pregabalin
Official title: Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intervertebral Disk Displacement
Disk Prolapse
Keywords: Intervertebral disk displacement
disk prolapse
pregabalin
Lead sponsor: Asker & Baerum Hospital
Sponsor class: OTHER
First posted: 2006-07-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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 postoperatively (p.o.)) gives significant better anxiolysis and analgesia than placebo.

The study is including patients undergoing surgery of the vertebral columna.

Eligibility criteria: 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

Primary outcomes:
measure: Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)
timeFrame: 120 minutes after surgery
Secondary outcomes:
measure: Morphine (Opioid) Consumption Cumulated
timeFrame: 240 minutes
Other outcomes:
Locations:
city: Rud
country: Norway
facility: Asker and Baerum Hospital
Study officials:
affiliation: Asker and Baerum Hospital, Norway
name: Ulrich J Spreng, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Asker and Baerum Hospital, Norway
name: Vegard Dahl, Dr. med.
role: STUDY_DIRECTOR
References:
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. doi: 10.1213/00000539-199377020-00026. No abstract available.
citation: 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.
citation: 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.
citation: 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.