ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001380482

Ethics application status

Approved

Date submitted

6/09/2016

Date registered

5/10/2016

Date last updated

15/04/2021

Date data sharing statement initially provided

15/04/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Impact of Intra-Articular Local Anesthetic Injection versus Femoral Nerve Block for Post-Operative Analgesia in Total Knee Arthroplasty.

Scientific title

Impact of Intra-Articular Local Anesthetic Injection versus Femoral Nerve Block for Post-Operative Analgesia in Total Knee Arthroplasty.

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1186-1612

Trial acronym

Linked study record

Health condition

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

knee arthritis posted for elective total knee replacement

ASA 1 or 2 patient posted for primary elective total knee replacement

post operative pain management

Condition category

Condition code

Anaesthesiology

Pain management

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

In INTRA-ARTICULAR (IA) group a cocktail anesthetic will be prepared containing 50ml of 0.25% Bupivaicaine, 10mg of morphine (1ml) and 99ml of normal saline, to make the total volume 150ml. This 150 ml of fluid will be injected at posterior capsule, anterior capsule, patellar tendon, quadriceps tendon and the subcutaneous tissue at incision line at the end of surgery by the operating surgeon.

Intervention code [1]

Treatment: Other

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

The patient of FEMORAL NERVE BLOCK SINGLE SHOT GROUP (FNB) group will receive a single injection femoral nerve block after the surgery by senior anaesthesiologist. A high resolution ultrasound device (sonosite) will be used to locate the femoral nerve. Direct visualization of needle tip will be maintained by ultrasound while inserting the needle, until needle reaches close to the femoral nerve. The site of injection will be confirmed by nerve stimulator after getting the ipsilateral quadriceps contraction (patellar movement) at 0.5 mA, (stimulator frequency at 2 Hz and pulse width of 0.1 sec). At this site, 25 ml of 0.5 % Bupivacaine will be injected slowly after negative aspiration. During the injection the spread of local anesthetic solution within the fascial space will be visualized by ultrasound. The injection can be stopped and needle will be repositioned if patient complains of pain during injection.

Control group

Active

Outcomes

Primary outcome [1]

patient controlled morphine consumption by review of the medical records.

Timepoint [1]

24 hours post surgery.

Secondary outcome [1]

Pain, assessed by Visual analogue scale 0-10

Timepoint [1]

every 4 hourly for first 24 hours post-surgery.

Secondary outcome [2]

nausea and vomiting by review of medical records.

Timepoint [2]

first 24 hours postoperative

Secondary outcome [3]

ambulation by review medical records.

Timepoint [3]

first 24 hours post surgery.

Eligibility

Key inclusion criteria

Primary elective total knee replacement
Patients fulfilling criteria 1-2 of American Society of Anesthesiologists (ASA)

Minimum age

40 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

ASA physical status 3 and above.
History of allergy/contraindications to morphine, local anesthetics, nonsteroidal anti-inflammatory drugs, paracetamol, central neuraxial block and peripheral nerve blocks
Regular opioid use
Peripheral neuropathies
History of chronic pain at site(s) other than joint replacement
Renal and/or hepatic impairment

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)

computer generated random allocation

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

computer sequence generator

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

chi-square, ANOVA , fischer-exact test.
and other as applicable test.
number of participants needed to achieve study objectives was determined on clinical and statistical assumptions.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

10/10/2016

Actual

18/10/2016

Date of last participant enrolment

Anticipated

19/10/2017

Actual

1/02/2018

Date of last data collection

Anticipated

Actual

4/02/2018

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Bahrain

State/province [1]

bahrain

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

king hamad university hospital

Address [1]

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

Country [1]

Bahrain

Primary sponsor type

Individual

Name

Shahid Adeel

Address

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

Country

Bahrain

Secondary sponsor category [1]

Individual

Name [1]

VISHAL HASMUKH SHAH

Address [1]

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

Country [1]

Bahrain

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

King Hamad University Hospital research and ethics committee

Ethics committee address [1]

Director of Research and Ethics
King Hamad University Hospital, Building 2435, Road 2835, Block 228, Busaiteen,  P. O. Box 24343, Kingdom of Bahrain

Ethics committee country [1]

Bahrain

Date submitted for ethics approval [1]

15/03/2016

Approval date [1]

27/06/2016

Ethics approval number [1]

Ref. KHUH/Research/No. 146/2016

Summary

Brief summary

The development of joint replacement is regarded as one of the most significant advances in orthopedic surgeries. Total knee replacement is associated with significant potential perioperative morbidity. In this regard, anesthesia is of prime importance to reduce postoperative pain and morbidity. Anesthesia for total knee replacement should provide stable intraoperative conditions and rapid recuperation. Analgesia techniques should aim to provide optimal pain relief whilst minimizing side effects. There is now good evidence that well conducted regional analgesia can achieve these aims, leading to improved functional recovery facilitated by more rapid and effective joint rehabilitation.
The usual choices for post-operative analgesia are epidural modes of analgesia, systemic opiates and peripheral nerve blocks. All these methods need to be complemented with NSAIDS or COX-2 selective inhibitors, paracetamol and gabapentenoids for effective management of break through high intensity pain. 
All these alternatives come with their own advantages and disadvantages.
Statement of the problem: The comparative analgesic effect of intraarticular local anesthetic injection and femoral nerve block has not been adequately reported in patients undergoing TKA.
Significance: Clinical trials investigating different modalities of administering analgesia in total knee replacement have reported comparative efficacies between single shot femoral nerve block (SSFNB) and intraarticular injections of local anesthetics with analgesic drugs. A recent retrospective study examining the pain rating, side effects and ambulation found that intraarticular injection with higher dose of local anesthetics provide comparable analgesic effect as single shot femoral nerve block after TKA and might be associated with early ambulation than femoral nerve block post-operatively.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/371267-Acceptance Letter - Dr. Shahid Adeel - Femoral Nerve Block.pdf (Ethics approval)

Contacts

Principal investigator

Name

Dr SHAHID ADEEL

Address

King Hamad University Hospital, Building 2435, Road 2835, Block 228, Busaiteen, Kingdom of Bahrain

Country

Bahrain

Phone

+97336282405

Fax

shahid.adeel@khuh.org.bh

Contact person for public queries

Name

VISHAL SHAH

Address

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

Country

Bahrain

Phone

+97339508223

Fax

fordrvishal@gmail.com

Contact person for scientific queries

Name

Shahid Adeel

Address

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

Country

Bahrain

Phone

+97336282405

Fax

shahid.adeel@khuh.org.bh

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?

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

No additional documents have been identified.

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