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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Intervertebral Disk Displacement
Disk Prolapse
Interventions Drug: pregabalin
Drug: Placebo
Drug: morphine
Enrollment 50
Recruitment Details recruitment period november 2005 until june 2008
Pre-assignment Details  
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 25 25
Completed 22 24
Not Completed 3 1
Reason Not Completed
Protocol Violation             3             1
Arm/Group Title Pregabalin Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
25
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
44  (11) 43  (8) 43  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
12
  48.0%
12
  48.0%
24
  48.0%
Male
13
  52.0%
13
  52.0%
26
  52.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Norway Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)
Hide Description 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.
Time Frame 120 minutes after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 22 24
Mean (Standard Deviation)
Unit of Measure: Units on a scale
11.7  (9.6) 22.5  (14.4)
2.Secondary Outcome
Title Morphine (Opioid) Consumption Cumulated
Hide Description 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)
Time Frame 240 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 22 24
Mean (Standard Deviation)
Unit of Measure: mg
7.3  (6.3) 16.0  (13.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/24 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/24 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ulrich J Spreng
Organization: Baerum Hospital
Phone: 004798499184
EMail: ulispreng@hotmail.com
Layout table for additonal information
Responsible Party: Ulrich Johannes Spreng, Asker and Baerum Hospital
ClinicalTrials.gov Identifier: NCT00353704    
Other Study ID Numbers: 2005-003229-20
First Submitted: July 17, 2006
First Posted: July 19, 2006
Results First Submitted: May 24, 2011
Results First Posted: July 20, 2011
Last Update Posted: July 20, 2011