Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623001360606
Ethics application status
Approved
Date submitted
11/08/2023
Date registered
21/12/2023
Date last updated
21/12/2023
Date data sharing statement initially provided
21/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of pregabalin on Total knee replacement post operative pain
Scientific title
Effect of Perioperative oral pregabalin in Total Knee replacement for postoperative pain
Secondary ID [1] 310373 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative Pain 331113 0
Total knee replacement 331201 0
Condition category
Condition code
Anaesthesiology 327898 327898 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
120 patients fulfilling the inclusion criteria will be included in this study. The patients will be randomly assigned into two equal groups; Group P: Pregablain group and Group C: control group. Group P will receive oral capsule pregabalin 75mg one hour preoperatively and Group C will not receive any premedication preoperatively. To ensure adherence to the intervention, empty drug blister will be returned to pharmacy.
Intraoperatively both groups will receive Inj. midazolam 2mg before subarachnoid block with hyperbaric Bupivacaine 0.5% 2.5-3ml and fentanyl 15mcg in the operation theatre (OT). Both groups will also receive parecoxib 40mg IV and paracetamol 1G Intravenous (IV) as part of multimodal analgesia. Both groups will receive dexamethasone 8mg IV prophylactically.
Postoperatively both group will receive Ultrasound guided Adductor canal Femoral Nerve block in the PACU with 0.2% Bupivacaine & dexmeditomidine1.0mcg/kg. Group P will receive oral capsule pregabalin 75 mg Q12hrly from the 1st dose for next 60 hrs. Group C will not receive any medication. Both groups will receive paracetamol 1G IV Q6Hrly for 24 hrs.
Rescue Analgesia will be provided with oral oxycodone 5mg TDS and Morphine S/C 4-5mg, in escalating manner as per patient requirement.
Intervention code [1] 326771 0
Treatment: Drugs
Comparator / control treatment
Control group: Group C will not receive any premedication preoperatively. But they will receive routinestandard perioperative care.
Control group
Active

Outcomes
Primary outcome [1] 335742 0
To measure Total Knee replacement Postoperative Pain by Visual Analogue Score 0-10
Timepoint [1] 335742 0
Postoperative at 4hrs, 8hrs, 12hrs, 24hrs, 36 hrs, 48hrs, 60hrs, and 72hrs.
Secondary outcome [1] 425432 0
Sedation score
Timepoint [1] 425432 0
Sedation score: RASS score postoperative at 4hrs, 8hrs, 12hrs, 24hrs, 36 hrs, 48hrs, 60hrs, 72hrs.
Secondary outcome [2] 425812 0
Total Opioids consumption at 72 hrs assessed from medical records of OPIODS Consumption, kept by nursing staff.
Timepoint [2] 425812 0
post operative 72 hrs
Secondary outcome [3] 425813 0
Patient satisfaction at 72 hrs : rated as numeric 1-5 (1=not satisfied, 5=fully satisfied)
Timepoint [3] 425813 0
Postoperative 72 Hrs

Eligibility
Key inclusion criteria
1. Age between 21 to 85 year
2. Elective Regional anesthesia.
3. Able to follow study protocol
Minimum age
21 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.ASA -IV
2.Age <18 & > 85 years
3.Patients on pregabalin for chronic neuropathic pain.
4.Patient under General anesthesia
5.Patients with chronic liver failure
6.Patients with chronic renal failure on Hemodialysis
7. Patients on opioid (>3 month)
8. Patient with complicated knee surgery.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
It is estimated that at least 60 subjects would be required per group in order to detect a difference of 1 pain score between groups with 90% power and 5 % probability of type 1 error.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/09/2023
Date of last participant enrolment
Anticipated
17/03/2025
Actual
Date of last data collection
Anticipated
20/03/2025
Actual
Sample size
Target
120
Accrual to date
14
Final
Recruitment outside Australia
Country [1] 25716 0
Bahrain
State/province [1] 25716 0
manama

Funding & Sponsors
Funding source category [1] 314576 0
Hospital
Name [1] 314576 0
Bahrain defence forces hospital, royal medical services
Country [1] 314576 0
Bahrain
Primary sponsor type
Hospital
Name
Bahrain defence forces hospital, royal medical services
Address
BDF hospital Road 2817, block 381, West riffa Kingdom of Bahrain
Country
Bahrain
Secondary sponsor category [1] 316538 0
Hospital
Name [1] 316538 0
Bahrain defence forces hospital
Address [1] 316538 0
BDF hospital Road 2817, block 381, West riffa Kingdom of Bahrain
Country [1] 316538 0
Bahrain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313610 0
Crown Prince Training and research centre, Bahrain defence forces.
Ethics committee address [1] 313610 0
Ethics committee country [1] 313610 0
Bahrain
Date submitted for ethics approval [1] 313610 0
19/02/2023
Approval date [1] 313610 0
08/08/2023
Ethics approval number [1] 313610 0
BDF/R & REC/2023-674

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128742 0
Dr Mehtash Butt
Address 128742 0
BDF hospital Road 2817, block 381, West riffa Kingdom of Bahrain
Country 128742 0
Bahrain
Phone 128742 0
+97336681277
Fax 128742 0
Email 128742 0
[email protected]
Contact person for public queries
Name 128743 0
Mehtash butt
Address 128743 0
BDF hospital Road 2817, block 381, West riffa Kingdom of Bahrain
Country 128743 0
Bahrain
Phone 128743 0
+97336681277
Fax 128743 0
Email 128743 0
[email protected]
Contact person for scientific queries
Name 128744 0
Mehtash Butt
Address 128744 0
BDF hospital Road 2817, block 381, West riffa Kingdom of Bahrain
Country 128744 0
Bahrain
Phone 128744 0
+97336681277
Fax 128744 0
Email 128744 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Only researchers and data analysts and statisticians

Conditions for requesting access:
• -

What individual participant data might be shared?
• Age
sex
weight
Height
BMI
Vas
Rass
Morphine consumption
patient satisfaction

What types of analyses could be done with individual participant data?
• Any purpose

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 10 years
Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approvals by Principal Investigator
[email protected]
[email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19991Ethical approval    Study-related document.pdf
19992Study protocol    Study-related document.pdf
19993Informed consent form    Study-related document.docx


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19991Ethical approval    Study-related document.pdf
19992Study protocol    protocol 1.1 pregabalin strata randomized.pdf
19993Informed consent form    14. Informed Consent Form NHRA modified.pdf
24425Other    15. Case Report Form 1.1.pdf

Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.