Analgetic and Anxiolytic Effect of Preoperative Pregabalin - Full Text View

Sponsor:	Asker & Baerum Hospital
Information provided by:	Asker & Baerum Hospital
ClinicalTrials.gov Identifier:	NCT00353704

Purpose

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.

Condition	Intervention	Phase
Intervertebral Disk Displacement Disk Prolapse	Drug: pregabalin Drug: Placebo Drug: morphine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Herniated Disk

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by Asker & Baerum Hospital:

Primary Outcome Measures:

Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm) [ Time Frame: 120 minutes after surgery ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Morphine (Opioid) Consumption Cumulated [ Time Frame: 240 minutes ] [ Designated as safety issue: No ]
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)

Enrollment:	50
Study Start Date:	November 2005
Study Completion Date:	June 2010
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Pregabalin 150 mg Pregabalin per orally about one hour before surgery	Drug: pregabalin capsule 150 mg x 1 per orally one hour before surgery Drug: 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 Comparator: Placebo One capsule of saccharose (placebo) was administered orally about one hour before surgery.	Drug: Placebo One capsule of saccharose (placebo) was administered about one hour before surgery Drug: morphine All patients were equipped with a PCA (patient controlled analgesia) for 24 hours after surgery. The sum of morphine used was registered (milligram).

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353704

Locations

Norway
Asker and Baerum Hospital
Rud, Norway, 1309

Sponsors and Collaborators

Asker & Baerum Hospital

Investigators

Principal Investigator:	Ulrich J Spreng, Dr. med.	Asker and Baerum Hospital, Norway
Study Director:	Vegard Dahl, Dr. med.	Asker and Baerum Hospital, Norway

More Information

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. 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):1394-9, 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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Mar 8.

Responsible Party:	Ulrich Johannes Spreng, Asker and Baerum Hospital
ClinicalTrials.gov Identifier:	NCT00353704 History of Changes
Other Study ID Numbers:	2005-003229-20
Study First Received:	July 17, 2006
Results First Received:	May 24, 2011
Last Updated:	July 19, 2011
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by Asker & Baerum Hospital:

Intervertebral disk displacement
disk prolapse
pregabalin

Additional relevant MeSH terms:

Intervertebral Disk Displacement
Prolapse
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical
Morphine
Pregabalin
Anti-Anxiety Agents
Analgesics, Opioid
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Tranquilizing Agents
Psychotropic Drugs
Anticonvulsants

ClinicalTrials.gov processed this record on February 13, 2012