Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000591459
Ethics application status
Approved
Date submitted
30/03/2016
Date registered
6/05/2016
Date last updated
12/04/2017
Type of registration
Prospectively registered

Titles & IDs
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.
Secondary ID [1] 288884 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lumbar stabilisation procedures 298184 0
Condition category
Condition code
Anaesthesiology 298348 298348 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 294342 0
Treatment: Drugs
Comparator / control treatment
Group 1 (pregabalin only) is the control group.
Control group
Active

Outcomes
Primary outcome [1] 297816 0
postoperative analgesia which evaluated by 100 mm Visual Analog Scale (VAS)
Timepoint [1] 297816 0
postoperative 0,1,2,4,8,12,24,36,48. hour.
Secondary outcome [1] 322340 0
Patient satisfaction score which evaluated by 100 mm visual analog scale.
Timepoint [1] 322340 0
24. and 48. postoperative hour.

Eligibility
Key inclusion criteria
ASA ( american society of anesthesiologists) Physical Status 1-2,
planned for elective posterior lumbar stabilisation surgery
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Antiepileptic drug use, ASA 3 patient groups, Mild or severe renal insufficiency.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2016
Date of last participant enrolment
Anticipated
1/09/2016
Actual
20/09/2016
Date of last data collection
Anticipated
Actual
22/09/2016
Sample size
Target
42
Accrual to date
Final
42
Recruitment outside Australia
Country [1] 7757 0
Turkey
State/province [1] 7757 0
Konya

Funding & Sponsors
Funding source category [1] 293233 0
University
Name [1] 293233 0
Baskent University Research Fund
Country [1] 293233 0
Turkey
Primary sponsor type
University
Name
Baskent University
Address
Taskent Caddesi (Eski 1. Cadde) 77. Sokak (Eski 16. Sokak) No:11 06490 Bahcelievler / ANKARA / Turkey
Country
Turkey
Secondary sponsor category [1] 292036 0
None
Name [1] 292036 0
Address [1] 292036 0
Country [1] 292036 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294713 0
baskent University Institutional Review Board and Ethics Committee
Ethics committee address [1] 294713 0
Taskent Caddesi (Eski 1. Cadde) 77. Sokak (Eski 16. Sokak) No:11 06490 Bahcelievler / ANKARA / Turkey
Ethics committee country [1] 294713 0
Turkey
Date submitted for ethics approval [1] 294713 0
01/02/2016
Approval date [1] 294713 0
18/03/2016
Ethics approval number [1] 294713 0
KA 16/71

Summary
Brief summary
For managing acute postoperative pain, new medical treatments administered preoperatively. For this purpose, pregabalin has been used previously for lumbar fusion surgery in some clinical research. Intravenous ibuprofen ( NSAID analgesic) used until 2009. We want to investigate the effect of pregabalin+intravenous ibuprofen used before the operation preemptively on postoperative analgesia for lumbar fusion surgery.
We enroll 42 patients who undergone elective lumbar fusion surgery. Exclusion criteria; antiepileptic drug use, allergic reaction for study drugs, ASA III-IV patients. mild or severe renal insufficiency.
Group Pregabalin: 1 hour before operation patients will take 150 mg pregabalin oral form.
Group Pregabalin + intravenous ibuprofen: 1 hour before operation patients will take 150 mg pregabalin oral form. Additionally 1/2 hour before operation patients will take 800 mg intravenous ibuprofen.
After operation we give patient controlled analgesia contains morphine, and we will evaluate postoperative pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64790 0
Dr huseyin ulas pinar
Address 64790 0
Baskent University Konya Research and Application Center Hocacihan Mah Saray cad no:1 42080 selcuklu/Konya
Country 64790 0
Turkey
Phone 64790 0
+903322570606
Fax 64790 0
+903322570637
Email 64790 0
[email protected]
Contact person for public queries
Name 64791 0
huseyin ulas pinar
Address 64791 0
Baskent University Konya Research and Application Center Hocacihan mah saray cad no:1 42080 selcuklu/Konya
Country 64791 0
Turkey
Phone 64791 0
+903322570606
Fax 64791 0
+903322570637
Email 64791 0
[email protected]
Contact person for scientific queries
Name 64792 0
huseyin ulas pinar
Address 64792 0
Baskent University Konya Research and Application Center hocacihan mah saray cad no:1 42080 selcuklu/Konya
Country 64792 0
Turkey
Phone 64792 0
+903322570606
Fax 64792 0
+903322570637
Email 64792 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of Addition of Preoperative Intravenous Ibuprofen to Pregabalin on Postoperative Pain in Posterior Lumbar Interbody Fusion Surgery.2017https://dx.doi.org/10.1155/2017/1030491
N.B. These documents automatically identified may not have been verified by the study sponsor.