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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] 289893 0
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 299851 0
ASA 1 or 2 patient posted for primary elective total knee replacement 299855 0
post operative pain management 300398 0
Condition category
Condition code
Anaesthesiology 299760 299760 0 0
Pain management
Musculoskeletal 300262 300262 0 0
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] 295571 0
Treatment: Other
Intervention code [2] 295989 0
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] 299220 0
patient controlled morphine consumption by review of the medical records.
Timepoint [1] 299220 0
24 hours post surgery.
Secondary outcome [1] 326549 0
Pain, assessed by Visual analogue scale 0-10
Timepoint [1] 326549 0
every 4 hourly for first 24 hours post-surgery.
Secondary outcome [2] 327964 0
nausea and vomiting by review of medical records.
Timepoint [2] 327964 0
first 24 hours postoperative
Secondary outcome [3] 327965 0
ambulation by review medical records.
Timepoint [3] 327965 0
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?
No
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
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 8087 0
Bahrain
State/province [1] 8087 0
bahrain

Funding & Sponsors
Funding source category [1] 294261 0
Hospital
Name [1] 294261 0
king hamad university hospital
Country [1] 294261 0
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] 293096 0
Individual
Name [1] 293096 0
VISHAL HASMUKH SHAH
Address [1] 293096 0
King Hamad University Hospital, Building 2435, Road 2835, Block 228, Busaiteen, P. O. Box 24343, Kingdom of Bahrain
Country [1] 293096 0
Bahrain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295689 0
King Hamad University Hospital research and ethics committee
Ethics committee address [1] 295689 0
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] 295689 0
Bahrain
Date submitted for ethics approval [1] 295689 0
15/03/2016
Approval date [1] 295689 0
27/06/2016
Ethics approval number [1] 295689 0
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] 1007 1007 0 0
/AnzctrAttachments/371267-Acceptance Letter - Dr. Shahid Adeel - Femoral Nerve Block.pdf (Ethics approval)

Contacts
Principal investigator
Name 68126 0
Dr SHAHID ADEEL
Address 68126 0
King Hamad University Hospital, Building 2435, Road 2835, Block 228, Busaiteen, Kingdom of Bahrain
Country 68126 0
Bahrain
Phone 68126 0
+97336282405
Fax 68126 0
Email 68126 0
[email protected]
Contact person for public queries
Name 68127 0
VISHAL SHAH
Address 68127 0
King Hamad University Hospital, Building 2435, Road 2835, Block 228, Busaiteen, P. O. Box 24343, Kingdom of Bahrain
Country 68127 0
Bahrain
Phone 68127 0
+97339508223
Fax 68127 0
Email 68127 0
[email protected]
Contact person for scientific queries
Name 68128 0
Shahid Adeel
Address 68128 0
King Hamad University Hospital, Building 2435, Road 2835, Block 228, Busaiteen, P. O. Box 24343, Kingdom of Bahrain
Country 68128 0
Bahrain
Phone 68128 0
+97336282405
Fax 68128 0
Email 68128 0
[email protected]

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?

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.