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Analgetic and Anxiolytic Effect of Preoperative Pregabalin
This study is currently recruiting participants.
Verified by Asker & Baerum Hospital, May 2008
First Received: July 17, 2006   Last Updated: May 6, 2008   History of Changes
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:


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:
    Drug: pregabalin
    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:
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