Analgetic and Anxiolytic Effect of Preoperative Pregabalin - Full Text View

Sponsored by:	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 is the purpose of this study 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	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
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: Herniated Disk

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by Asker & Baerum Hospital:

Primary Outcome Measures:

Analgetic effect (VAS) [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mobilisation [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Satisfaction [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	November 2005
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Intervention Details:

150 mg x 1

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 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 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

Contacts

Contact: Ulrich J Spreng, Dr. med.	47-6780-9400	ulrich.spreng@sabhf.no
Contact: Vegard Dahl, Dr. med.	47-9780-9400	vegard.dahl@sabhf.no

Locations

Norway
Asker and Baerum Hospital	Recruiting
Rud, Norway, 1309
Contact: Ulrich J Spreng, Dr. med. 47-6780-9400 ulrich.spreng@sabhf.no

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.

Responsible Party:	Asker and Baerum Hospital ( Ulrich Johannes Spreng )
Study ID Numbers:	2005-003229-20
Study First Received:	July 17, 2006
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00353704 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by Asker & Baerum Hospital:

Intervertebral disk displacement
laminectomy
disk prolapse
pregabalin

Study placed in the following topic categories:

Spinal Diseases
Pathological Conditions, Anatomical
Tranquilizing Agents
Psychotropic Drugs
Pregabalin
Central Nervous System Depressants
Prolapse

Bone Diseases
Musculoskeletal Diseases
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Intervertebral Disk Displacement
Anticonvulsants

Additional relevant MeSH terms:

Spinal Diseases
Pathological Conditions, Anatomical
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Pregabalin
Central Nervous System Depressants
Prolapse
Bone Diseases
Pharmacologic Actions

Musculoskeletal Diseases
Sensory System Agents
Therapeutic Uses
Anti-Anxiety Agents
Peripheral Nervous System Agents
Analgesics
Intervertebral Disk Displacement
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on July 06, 2009