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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 19 April 2021
Main ID:  ACTRN12616001380482
Date of registration: 05/10/2016
Prospective Registration: Yes
Primary sponsor: Shahid Adeel
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.
Date of first enrolment: 18/10/2016
Target sample size: 60
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12616001380482.aspx
Study type:  Interventional
Study design:  Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;  
Phase:  Phase 4
Countries of recruitment
Bahrain
Contacts
Name: Dr VISHAL SHAH   
Address:  King Hamad University Hospital, Building 2435, Road 2835, Block 228, Busaiteen, P. O. Box 24343, Kingdom of Bahrain Bahrain
Telephone: +97339508223
Email: fordrvishal@gmail.com
Affiliation: 
Name: Dr Shahid Adeel   
Address:  King Hamad University Hospital, Building 2435, Road 2835, Block 228, Busaiteen, P. O. Box 24343, Kingdom of Bahrain Bahrain
Telephone: +97336282405
Email: shahid.adeel@khuh.org.bh
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Primary elective total knee replacement
Patients fulfilling criteria 1-2 of American Society of Anesthesiologists (ASA)

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


Age minimum: 40 Years
Age maximum: 80 Years
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Anaesthesiology - Pain management
knee arthritis posted for elective total knee replacement;ASA 1 or 2 patient posted for primary elective total knee replacement;post operative pain management;
knee arthritis posted for elective total knee replacement
ASA 1 or 2 patient posted for primary elective total knee replacement
post operative pain management
Musculoskeletal - Osteoarthritis
Intervention(s)
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.
Primary Outcome(s)
patient controlled morphine consumption by review of the medical records.[24 hours post surgery.]
Secondary Outcome(s)
ambulation by review medical records.[first 24 hours post surgery.]
nausea and vomiting by review of medical records.[first 24 hours postoperative ]
Pain, assessed by Visual analogue scale 0-10
[every 4 hourly for first 24 hours post-surgery.]
Secondary ID(s)
none
Source(s) of Monetary Support
king hamad university hospital
Secondary Sponsor(s)
VISHAL HASMUKH SHAH
Ethics review
Status: Approved
Approval date: 27/06/2016
Contact:
Results
Results available: Yes
Date Posted: 15/04/2021
Date Completed: 04/02/2018
URL:
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