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Analgetic and Anxiolytic Effect of Preoperative Pregabalin

Information source: Asker & Baerum Hospital
ClinicalTrials.gov processed this data on August 23, 2015
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

Status: Completed

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

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.

Clinical Details

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Asker and Baerum Hospital, Rud 1309, Norway
Additional Information

Related publications:

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

Page last updated: August 23, 2015

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