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Trial record 37 of 976 for:    scale | Norway

Analgetic and Anxiolytic Effect of Preoperative Pregabalin

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ClinicalTrials.gov Identifier: NCT00353704
Recruitment Status : Completed
First Posted : July 19, 2006
Results First Posted : July 20, 2011
Last Update Posted : July 20, 2011
Sponsor:
Information provided by:
Asker & Baerum Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Intervertebral Disk Displacement Disk Prolapse Drug: pregabalin Drug: Placebo Drug: morphine Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna
Study Start Date : November 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herniated Disk
Drug Information available for: Pregabalin

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm) [ Time Frame: 120 minutes after surgery ]
    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 :
  1. Morphine (Opioid) Consumption Cumulated [ Time Frame: 240 minutes ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00353704


Locations
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Norway
Asker and Baerum Hospital
Rud, Norway, 1309
Sponsors and Collaborators
Asker & Baerum Hospital
Investigators
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Principal Investigator: Ulrich J Spreng, Dr. med. Asker and Baerum Hospital, Norway
Study Director: Vegard Dahl, Dr. med. Asker and Baerum Hospital, Norway

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ulrich Johannes Spreng, Asker and Baerum Hospital
ClinicalTrials.gov Identifier: NCT00353704     History of Changes
Other Study ID Numbers: 2005-003229-20
First Posted: July 19, 2006    Key Record Dates
Results First Posted: July 20, 2011
Last Update Posted: July 20, 2011
Last Verified: July 2011

Keywords provided by Asker & Baerum Hospital:
Intervertebral disk displacement
disk prolapse
pregabalin

Additional relevant MeSH terms:
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Prolapse
Intervertebral Disc Displacement
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Morphine
Pregabalin
Anti-Anxiety Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tranquilizing Agents
Psychotropic Drugs