ANZCTR - Registration

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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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Post operative analgesia

total knee arthroplasty

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Anaesthesiology

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]

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]

Pain score at rest

Timepoint [1]

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]

Pain score at movement

Timepoint [2]

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]

Early mobilisation

Timepoint [1]

Physiotherapy assessed 2 hours after patient arrival to ward.

Secondary outcome [2]

Patient satisfaction

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Bahrain

State/province [1]

Manama

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

King Hamad University Hospital

Address [1]

Country [1]

Bahrain

Primary sponsor type

Hospital

Name

King Hamad University Hospital

Address

Country

Bahrain

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

King Hamad University Hospital

Ethics committee address [1]

Building 2435, Road 2835 Block 228, P.O Box 24343, Busaiteen, Kingdom of Bahrain

Ethics committee country [1]

Bahrain

Date submitted for ethics approval [1]

15/11/2021

Approval date [1]

08/12/2021

Ethics approval number [1]

Summary

Brief summary

1. The purpose of the study is to compare analgesic effect of Adductor canal block ( ACB ) and femoral nerve block ( FNB ) in patients undergoing Total Knee Arthroplasty.
2. The block will be done with 20mls of 0.25% Bupivacaine in femoral nerve block and adductor canal block. 
3.Hypothesis:  Adductor canal block offers similar pain relief in comparison to femoral nerve block with less motor weakness aiding early mobilization.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Surendranath Venkatesan

Address

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

Bahrain

Phone

+973 38894263

Fax

[email protected]

Contact person for public queries

Name

Surendranath Venkatesan

Address

Department of Anaesthesia, King Hamad University Hospital, Building 2435, Road 2835 Block 228, P.O Box 24343, Busaiteen, Kingdom of Bahrain'.

Country

Bahrain

Phone

+973 38894263

Fax

[email protected]

Contact person for scientific queries

Name

Surendranath Venkatesan

Address

Department of Anaesthesia, King Hamad University Hospital, Building 2435, Road 2835 Block 228, P.O Box 24343, Busaiteen, Kingdom of Bahrain'.

Country

Bahrain

Phone

+973 38894263

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
21536	Study protocol			[email protected]		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.

Trial Review

Documents added manually

Documents added automatically