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Trial registered on ANZCTR


Registration number
ACTRN12618000521224
Ethics application status
Approved
Date submitted
22/12/2017
Date registered
9/04/2018
Date last updated
5/06/2019
Date data sharing statement initially provided
5/06/2019
Date results information initially provided
5/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the effect of Preoperative Pregabalin and Duloxetine on Postoperative Pain and Cognitive Function After Spinal Surgery
Scientific title
Comparison of Preoperative Pregabalin and Duloxetine on Postoperative Pain and Cognitive Function of Adult Patients Undergoing Spinal Surgery
Secondary ID [1] 293659 0
Nil Known
Universal Trial Number (UTN)
U1111-1206-8819
Trial acronym
PDT
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain after elective decompression laminectomy for lumbar disc herniation 305946 0
Cognitive function after elective laminectomy for lumbar disc herniation 305949 0
Condition category
Condition code
Anaesthesiology 305140 305140 0 0
Pain management
Mental Health 305141 305141 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The adult patients scheduled for elective repair of lumbar disc herniation will randomly be divided into three groups. The randomization will be based on a computerized randomization table created by a researcher who will not involve in the study. The patients assigned in the first group will orally receive 75 mg pregabalin one hour before the operation. The dose (75 mg) will be repeated orally at the postoperative 12th and 24th hour, The patients in the second group will orally receive 60 mg duloxetine one hour before the operation. At the postoperative 12th hour, the patients in the second group will receive a matched-place capsule and at the 24th hour, they will orally receive 60 mg duloxetine again. The patients in the third group will orally receive matching placebo capsules at all time-points. One of the researchers who will be blind to the study groups and study drugs will directly observe the patients while receiving the capsules. At the end of the operation, 1 mg/kg intravenous tramadol will be applied to all of the patients for postoperative pain control. All of the patients will be assessed with Montreal Cognitive Assessment evaluations for cognitive function evaluation at the day before the operation and six hours after the operation. Postoperative pain evaluation will be done according to visual analog scale by a researcher who will be blinded to the study groups at the postoperative first minute, 30. minute, first hour, 12. hour, 24. and 48 hour.
Intervention code [1] 299920 0
Treatment: Drugs
Comparator / control treatment
The patients in the third group will orally receive matching microcellulose placebo capsules which will be created by hospital pharmacy department. At the end of the operation, 1 mg/kg tramadol will be applied to all of the patients for postoperative pain control.
Control group
Placebo

Outcomes
Primary outcome [1] 304298 0
.To compare the reduction in postoperative first hour pain scores as assessed by 100mm visual analogue scale after preoperative administration of pregabalin 75 mg and duloxetine 60 mg
Timepoint [1] 304298 0
At postoperative first minute, 30th minute, first hour (primary timepoint), second hour, 12th hour, 24th hour and 48th hour
Primary outcome [2] 305067 0
To compare the effect of preoperatively administered pregabalin 75 mg and duloxetine 60 mg on postoperative cognitive functions as assessed by 30 point Montreal Cognitive Assessment Test
Timepoint [2] 305067 0
At the postoperative 6th hour
Primary outcome [3] 305068 0
.To compare the reduction in postoperative 48th hour pain scores as assessed by 100mm visual analogue scale after preoperative administration of pregabalin 75 mg and duloxetine 60 mg
Timepoint [3] 305068 0
At the postoperative 48th hour
Secondary outcome [1] 341520 0
To determine the side-effects such as nausea, vomiting and dizziness by directly asking the patient at different timepoints, or hypotension and hypertension by analyzing the nurse-care records at the ward
Timepoint [1] 341520 0
At the postoperative first minute, 6th, 12th, 24th and 48th hour

Eligibility
Key inclusion criteria
Age between 18-65, ASA I, II and III, patients with lumbar disc herniation
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known allergy for study drugs, impaired hepatic and/or renal function, history of chronic use of analgesics, alcohol and drug abuse, morbidly obese patients, patients with a preoperative Montreal cognitive assessment evaluation score under 24

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)
central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
None
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Statistical analysis will be performed by the SPSS System (version 15.0, SPSS Inc., Chicago, IL, USA). Values will be expressed as mean±standard deviation or as percentages. The groups will be compared in parametric parameters using Kruskal-Wallis test and in non-parametric parameters using Mann-Whitney U test. The percentage will be calculated in presence and absence group by Pearson's Chi-square test. p< 0.05 will be accepted statistically significant.
Sample size of the study was calculated based on previous studies in which preoperative pregabalin caused a f=0.20 difference in postoperative VAS scores and with a 2-sided significance level of .05, power of 0.92, 26 participants were needed per treatment group. Considering drop-out ratio as 10%, 30 participants per group were included in the study

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9458 0
Turkey
State/province [1] 9458 0
Mugla

Funding & Sponsors
Funding source category [1] 298276 0
Hospital
Name [1] 298276 0
Hacettepe University Hospital
Address [1] 298276 0
Hacettepe Mahallesi Altindag. 06230 Ankara Türkiye
Country [1] 298276 0
Turkey
Primary sponsor type
Individual
Name
Basak ALTIPARMAK
Address
Work organisation address: Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country
Turkey
Secondary sponsor category [1] 297395 0
None
Name [1] 297395 0
none
Address [1] 297395 0
none
Country [1] 297395 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299279 0
Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
Ethics committee address [1] 299279 0
Mugla Sitki Koçman University Training and Research Hospital, Marmaris Yolu üzeri, M Kapi Karsisi, 48000 Mugla
Ethics committee country [1] 299279 0
Turkey
Date submitted for ethics approval [1] 299279 0
09/02/2017
Approval date [1] 299279 0
10/02/2017
Ethics approval number [1] 299279 0
Approval number: VI

Summary
Brief summary
The primary aim of this study is to compare the effect of preoperative pregabalin and duloxetine on postoperative pain scores and cognitive functions of the patients undergoing spinal surgery. Our hypothesis is that both pregabalin and duloxetin will attenuate postoperative pain scores when compared to placebo group. Our secondary aim is to observe the side-effects related to study drugs. Our hypothesis is that the study drugs will not cause significant side-effects in the postoperative period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79890 0
Dr Basak ALTIPARMAK
Address 79890 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 79890 0
Turkey
Phone 79890 0
+905326726533
Fax 79890 0
Email 79890 0
basakugurlu@me.com
Contact person for public queries
Name 79891 0
Dr Basak ALTIPARMAK
Address 79891 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 79891 0
Turkey
Phone 79891 0
+905326726533
Fax 79891 0
Email 79891 0
basakugurlu@me.com
Contact person for scientific queries
Name 79892 0
Dr Basak ALTIPARMAK
Address 79892 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 79892 0
Turkey
Phone 79892 0
+905326726533
Fax 79892 0
Email 79892 0
basakugurlu@me.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Between December 2018 (publication date of the article) to December 2019 (one year after publication)
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator
What supporting documents are/will be available?
Study protocol
Clinical study report
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Other publications
Have study results been made publicly available in another format?
Yes
Results – basic reporting
Results – plain English summary