Analgetic and Anxiolytic Effect of Preoperative Pregabalin

This study has been completed.

Study NCT00353704 Information provided by Asker & Baerum Hospital

First Received on July 17, 2006. Last Updated on July 19, 2011 History of Changes

Results First Received: May 24, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Intervertebral Disk Displacement Disk Prolapse
Interventions:	Drug: pregabalin Drug: Placebo Drug: morphine

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
recruitment period november 2005 until june 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Pregabalin	No text entered.
Placebo	No text entered.

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Pregabalin	No text entered.
Placebo	No text entered.

Baseline Measures

	Pregabalin	Placebo	Total
Number of Participants [units: participants]	25	25	50
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	25	25	50
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	44 ± 11	43 ± 8	43 ± 10
Gender [units: participants]
Female	12	12	24
Male	13	13	26
Region of Enrollment [units: participants]
Norway	25	25	50

Outcome Measures

1. Primary:

Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm) [ Time Frame: 120 minutes after surgery ]

Show Outcome Measure 1

2. Secondary:

Morphine (Opioid) Consumption Cumulated [ Time Frame: 240 minutes ]

Show Outcome Measure 2

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Ulrich J Spreng
Organization: Baerum Hospital
phone: 004798499184
e-mail: ulispreng@hotmail.com

Publications:

Publications automatically indexed to this study:

Responsible Party:	Ulrich Johannes Spreng, Asker and Baerum Hospital
ClinicalTrials.gov Identifier:	NCT00353704 History of Changes
Other Study ID Numbers:	2005-003229-20
Study First Received:	July 17, 2006
Results First Received:	May 24, 2011
Last Updated:	July 19, 2011
Health Authority:	Norway: Norwegian Medicines Agency