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Analgetic and Anxiolytic Effect of Preoperative Pregabalin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 17, 2006
First Posted Date  ICMJE July 19, 2006
Results First Submitted Date  ICMJE May 24, 2011
Results First Posted Date  ICMJE July 20, 2011
Last Update Posted Date July 20, 2011
Study Start Date  ICMJE November 2005
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2006)
  • Anxiolytic effect (verbal rating)
  • Analgetic effect (VAS)
Change History Complete list of historical versions of study NCT00353704 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2011)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2006)
  • Mobilisation
  • Satisfaction
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analgetic and Anxiolytic Effect of Preoperative Pregabalin
Official Title  ICMJE Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Intervertebral Disk Displacement
  • Disk Prolapse
Intervention  ICMJE
  • Drug: pregabalin
    capsule 150 mg x 1 per orally 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).
Study Arms  ICMJE
  • Active Comparator: Pregabalin
    150 mg Pregabalin per orally about one hour before surgery
    Interventions:
    • Drug: pregabalin
    • Drug: morphine
  • Placebo Comparator: Placebo
    One capsule of saccharose (placebo) was administered orally about one hour before surgery.
    Interventions:
    • Drug: Placebo
    • Drug: morphine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2006)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00353704
Other Study ID Numbers  ICMJE 2005-003229-20
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ulrich Johannes Spreng, Asker and Baerum Hospital
Study Sponsor  ICMJE Asker & Baerum Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ulrich J Spreng, Dr. med. Asker and Baerum Hospital, Norway
Study Director: Vegard Dahl, Dr. med. Asker and Baerum Hospital, Norway
PRS Account Asker & Baerum Hospital
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP