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Trial registered on ANZCTR


Registration number
ACTRN12624000616572
Ethics application status
Approved
Date submitted
30/01/2024
Date registered
13/05/2024
Date last updated
13/05/2024
Date data sharing statement initially provided
13/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to compare between 2 pain relief blocks after total knee arthroplasty surgery.
Scientific title
Impact of adductor canal block versus femoral nerve block for post-operative analgesia in total knee arthroplasty.
Secondary ID [1] 311439 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative analgesia 332728 0
total knee arthroplasty 333235 0
Condition category
Condition code
Musculoskeletal 329445 329445 0 0
Osteoarthritis
Anaesthesiology 329922 329922 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients are randomly assigned to receive either adductor canal block (group A, interventional) or femoral nerve block (group B, comparator) after total knee arthroplasty as a part of post operative analgesia. An ultrasound guided single shot adductor canal block will be done after the surgery is completed and sterile dressing is applied. The block in this group will be done with 20 mls of 0.25% Bupivacaine. One dedicated consultant anaesthetist will be assigned to this group to perform the block to avoid inter individual block performance bias. A pain nurse followed up the patient in recovery and in ward and collected patient data, who was blinded to the study group to which the patient is assigned.

Patient Control Analgesia was prescribed for all patients with morphine and it will be prepared as an intravenous infusion with morphine 30mg taken in 12 ml Normal Saline, diluted to 2 mg/ml concentration. Analgesia will be self administered by patient using a automatic pump with each bolus dose administered delivering 1 mg per bolus dose with 5 minutes lockout interval and 30 mg maximum dose in 4 hours for 24 hours. Patient will receive multimodal analgesia for pain control after the surgery with paracetamol 1 g four times a day. Both groups will receive same protocol to avoid bias. Early mobilisation and patient satisfaction data were collected.
Intervention code [1] 327881 0
Treatment: Drugs
Comparator / control treatment
The femoral nerve block will be done after the surgery is completed and sterile dressing is applied. An ultrasound guided single shot femoral nerve block in this group will be done with 20 mls of 0.25% Bupivacaine. One dedicated consultant anaesthetist will be assigned to this group to perform the block, to avoid inter individual block performance bias. A pain nurse followed up the patient in recovery and in ward and collected patient data, who was blinded to the study group to which the patient is assigned. Patient Controlled Analgesia with Morphine will be prescribed as per the protocol described in Group A.
Control group
Active

Outcomes
Primary outcome [1] 337263 0
Pain score at rest
Timepoint [1] 337263 0
As the block in both groups were done just before shifting the patient from operating room to recovery, Pain score at rest baseline time (0 hours) was considered on arrival at recovery. Patients were followed up from thereafter every 6, 12, 18 and 24 hours by pain nurse in the ward.
Primary outcome [2] 338107 0
Pain score at movement
Timepoint [2] 338107 0
As the block in both groups were done just before shifting the patient from operating room to recovery, Pain score at movement baseline time (0 hours) was considered on arrival at recovery. Patients were followed up from thereafter every 6, 12, 18 and 24 hours by pain nurse in the ward.
Secondary outcome [1] 431258 0
Early mobilisation
Timepoint [1] 431258 0
Physiotherapy assessed 2 hours after patient arrival to ward.
Secondary outcome [2] 432832 0
Patient satisfaction
Timepoint [2] 432832 0
Interview conducted by pain nurse after 24 hours after surgery.

Eligibility
Key inclusion criteria
1. Patients undergoing primary Total Knee Arthroplasty (TKA),
2. Age 40–80 years of either sex,
3. The American Society of Anesthesiologists (ASA) Physical status classes I and II.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. ASA physical status classes > III,
2. History of allergy/contraindications to morphine, local anaesthetics, nonsteroidal anti-inflammatory drugs, paracetamol, central neuraxial block and peripheral nerve blocks
3. Patients who are receiving regular opioids.
4. Patients planned for complex TKA or revision TKAs.
5. Patient refusing consent.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2022
Date of last participant enrolment
Anticipated
Actual
30/12/2022
Date of last data collection
Anticipated
Actual
31/12/2022
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 26127 0
Bahrain
State/province [1] 26127 0
Manama

Funding & Sponsors
Funding source category [1] 315715 0
Hospital
Name [1] 315715 0
King Hamad University Hospital
Country [1] 315715 0
Bahrain
Primary sponsor type
Hospital
Name
King Hamad University Hospital
Address
Country
Bahrain
Secondary sponsor category [1] 317822 0
None
Name [1] 317822 0
Address [1] 317822 0
Country [1] 317822 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314580 0
King Hamad University Hospital
Ethics committee address [1] 314580 0
Ethics committee country [1] 314580 0
Bahrain
Date submitted for ethics approval [1] 314580 0
15/11/2021
Approval date [1] 314580 0
08/12/2021
Ethics approval number [1] 314580 0

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

Contacts
Principal investigator
Name 132074 0
Dr Surendranath Venkatesan
Address 132074 0
Department of Anaesthesia and Pain Medicine, King Hamad University Hospital, Building 2435, Road 2835 Block 228, P.O Box 24343, Busaiteen, Kingdom of Bahrain
Country 132074 0
Bahrain
Phone 132074 0
+973 38894263
Fax 132074 0
Email 132074 0
surendranath.venkatesan@khuh.org.bh
Contact person for public queries
Name 132075 0
Surendranath Venkatesan
Address 132075 0
Department of Anaesthesia, King Hamad University Hospital, Building 2435, Road 2835 Block 228, P.O Box 24343, Busaiteen, Kingdom of Bahrain'.
Country 132075 0
Bahrain
Phone 132075 0
+973 38894263
Fax 132075 0
Email 132075 0
surendranath.venkatesan@khuh.org.bh
Contact person for scientific queries
Name 132076 0
Surendranath Venkatesan
Address 132076 0
Department of Anaesthesia, King Hamad University Hospital, Building 2435, Road 2835 Block 228, P.O Box 24343, Busaiteen, Kingdom of Bahrain'.
Country 132076 0
Bahrain
Phone 132076 0
+973 38894263
Fax 132076 0
Email 132076 0
surendranath.venkatesan@khuh.org.bh

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21536Study protocol  surendranath.venkatesan@khuh.org.bh 387254-(Uploaded-30-01-2024-19-57-55)-Study-related document.docx



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.