Analgetic and Anxiolytic Effect of Preoperative Pregabalin

Intervertebral Disk Displacement Clinical Trial

Official title:

Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353704
• Other study ID #: 2005-003229-20
• Status: Completed
• Phase: Phase 4
• First received: July 17, 2006
• Last updated: July 19, 2011
• Start date: November 2005
• Est. completion date: June 2010

Study information

• Verified date: July 2011
• Source: Asker & Baerum Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disk Prolapse
• Intervertebral Disc Displacement
• Intervertebral Disk Displacement
• Prolapse

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Norway	Asker and Baerum Hospital	Rud

Sponsors (1)

Lead Sponsor	Collaborator
Asker & Baerum Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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

Outcome

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