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Analgetic and Anxiolytic Effect of Preoperative Pregabalin

Primary Purpose

Intervertebral Disk Displacement, Disk Prolapse

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
pregabalin
Placebo
morphine
Sponsored by
Asker & Baerum Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intervertebral Disk Displacement focused on measuring Intervertebral disk displacement, disk prolapse, pregabalin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asker and Baerum Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pregabalin

Placebo

Arm Description

150 mg Pregabalin per orally about one hour before surgery

One capsule of saccharose (placebo) was administered orally about one hour before surgery.

Outcomes

Primary Outcome Measures

Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)
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

Morphine (Opioid) Consumption Cumulated
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)

Full Information

First Posted
July 17, 2006
Last Updated
July 19, 2011
Sponsor
Asker & Baerum Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00353704
Brief Title
Analgetic and Anxiolytic Effect of Preoperative Pregabalin
Official Title
Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Asker & Baerum Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disk Displacement, Disk Prolapse
Keywords
Intervertebral disk displacement, disk prolapse, pregabalin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin
Arm Type
Active Comparator
Arm Description
150 mg Pregabalin per orally about one hour before surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One capsule of saccharose (placebo) was administered orally about one hour before surgery.
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
capsule 150 mg x 1 per orally one hour before surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One capsule of saccharose (placebo) was administered about one hour before surgery
Intervention Type
Drug
Intervention Name(s)
morphine
Intervention Description
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 Measure Information:
Title
Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)
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
Secondary Outcome Measure Information:
Title
Morphine (Opioid) Consumption Cumulated
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich J Spreng, Dr. med.
Organizational Affiliation
Asker and Baerum Hospital, Norway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vegard Dahl, Dr. med.
Organizational Affiliation
Asker and Baerum Hospital, Norway
Official's Role
Study Director
Facility Information:
Facility Name
Asker and Baerum Hospital
City
Rud
ZIP/Postal Code
1309
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
8346839
Citation
Woolf CJ, Chong MS. Preemptive analgesia--treating postoperative pain by preventing the establishment of central sensitization. Anesth Analg. 1993 Aug;77(2):362-79. doi: 10.1213/00000539-199377020-00026. No abstract available.
Results Reference
background
PubMed Identifier
15845693
Citation
Menigaux C, Adam F, Guignard B, Sessler DI, Chauvin M. Preoperative gabapentin decreases anxiety and improves early functional recovery from knee surgery. Anesth Analg. 2005 May;100(5):1394-1399. doi: 10.1213/01.ANE.0000152010.74739.B8.
Results Reference
background
PubMed Identifier
12218520
Citation
Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Anesthesiology. 2002 Sep;97(3):560-4. doi: 10.1097/00000542-200209000-00007.
Results Reference
background
PubMed Identifier
21385158
Citation
Spreng UJ, Dahl V, Raeder J. Effect of a single dose of pregabalin on post-operative pain and pre-operative anxiety in patients undergoing discectomy. Acta Anaesthesiol Scand. 2011 May;55(5):571-6. doi: 10.1111/j.1399-6576.2011.02410.x. Epub 2011 Mar 8.
Results Reference
derived

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Analgetic and Anxiolytic Effect of Preoperative Pregabalin

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