Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ANZCTR |
Last refreshed on:
|
13 January 2020 |
Main ID: |
ACTRN12616000591459 |
Date of registration:
|
06/05/2016 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
The efficacy of intravenous ibuprofen and pregabalin before posterior lumbar stabilisation surgery on postoperative pain.
|
Scientific title:
|
Comparison of pregabalin and pregabalin+ intravenous ibuprofen for preemptive (before the procedure) analgesia for posterior lumbar stabilisation operation. |
Date of first enrolment:
|
01/06/2016 |
Target sample size:
|
42 |
Recruitment status: |
Completed |
URL:
|
https://anzctr.org.au/ACTRN12616000591459.aspx |
Study type:
|
Interventional |
Study design:
|
Purpose: Treatment; Allocation: Randomised controlled trial;
|
Phase:
|
Phase 4
|
|
Countries of recruitment
|
Turkey
| | | | | | | |
Contacts
|
Name:
|
Mr huseyin ulas pinar
|
Address:
|
Baskent University Konya Research and Application Center Hocacihan mah saray cad no:1 42080 selcuklu/Konya
Turkey |
Telephone:
|
+903322570606 |
Email:
|
huseyinpinar2002@yahoo.com |
Affiliation:
|
|
|
Name:
|
Mr huseyin ulas pinar
|
Address:
|
Baskent University Konya Research and Application Center hocacihan mah saray cad no:1 42080 selcuklu/Konya
Turkey |
Telephone:
|
+903322570606 |
Email:
|
huseyinpinar2002@yahoo.com |
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: ASA ( american society of anesthesiologists) Physical Status 1-2,
planned for elective posterior lumbar stabilisation surgery
Exclusion criteria: Antiepileptic drug use, ASA 3 patient groups, Mild or severe renal insufficiency.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both males and females
|
Health Condition(s) or Problem(s) studied
|
Lumbar stabilisation procedures; Lumbar stabilisation procedures
|
Anaesthesiology - Pain management
|
Intervention(s)
|
For postoperative pain we will give one group of patients ( 21 patients for each group) pregabalin 150 mg oral form 1 hour before the operation. The other group will take pregabalin like group 1 and intravenous ibuprofen 800 mg, 1/2 hour before the operation.
|
Primary Outcome(s)
|
postoperative analgesia which evaluated by 100 mm Visual Analog Scale (VAS)[postoperative 0,1,2,4,8,12,24,36,48. hour.]
|
Secondary Outcome(s)
|
Patient satisfaction score which evaluated by 100 mm visual analog scale.[24. and 48. postoperative hour.]
|
Secondary ID(s)
|
Nil known
|
Source(s) of Monetary Support
|
Baskent University Research Fund
|
Ethics review
|
Status: Approved
Approval date:
Contact:
baskent University Institutional Review Board and Ethics Committee
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|