Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353704
Status:
COMPLETED
Last Update Posted:
2011-07-20
First Post:
2006-07-17
Brief Title:
Analgetic and Anxiolytic Effect of Preoperative Pregabalin
Sponsor:
Asker Baerum Hospital
Organization:
Asker Baerum Hospital
Study Overview
Official Title:
Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 po gives significant better anxiolysis and analgesia than placebo
The study is including patients undergoing surgery of the vertebral columna
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 po gives significant better anxiolysis and analgesia than placebo
The study is including patients undergoing surgery of the vertebral columna
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None