Main
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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:
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ANZCTR |
Last refreshed on:
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19 April 2021 |
Main ID: |
ACTRN12616001380482 |
Date of registration:
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05/10/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Impact of Intra-Articular Local Anesthetic Injection versus Femoral Nerve Block for Post-Operative Analgesia in Total Knee Arthroplasty.
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Scientific title:
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Impact of Intra-Articular Local Anesthetic Injection versus Femoral Nerve Block for Post-Operative Analgesia in Total Knee Arthroplasty. |
Date of first enrolment:
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18/10/2016 |
Target sample size:
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60 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12616001380482.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Phase 4
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Countries of recruitment
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Bahrain
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Contacts
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Name:
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Dr VISHAL SHAH
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Address:
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King Hamad University Hospital, Building 2435, Road 2835, Block 228, Busaiteen, P. O. Box 24343, Kingdom of Bahrain
Bahrain |
Telephone:
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+97339508223 |
Email:
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fordrvishal@gmail.com |
Affiliation:
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Name:
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Dr Shahid Adeel
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Address:
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King Hamad University Hospital, Building 2435, Road 2835, Block 228, Busaiteen, P. O. Box 24343, Kingdom of Bahrain
Bahrain |
Telephone:
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+97336282405 |
Email:
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shahid.adeel@khuh.org.bh |
Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Anaesthesiology - Pain management
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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
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Musculoskeletal - Osteoarthritis
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Intervention(s)
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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.
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Primary Outcome(s)
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patient controlled morphine consumption by review of the medical records.[24 hours post surgery.]
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Secondary Outcome(s)
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ambulation by review medical records.[first 24 hours post surgery.]
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nausea and vomiting by review of medical records.[first 24 hours postoperative ]
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Pain, assessed by Visual analogue scale 0-10
[every 4 hourly for first 24 hours post-surgery.]
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Source(s) of Monetary Support
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king hamad university hospital
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Ethics review
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Status: Approved
Approval date: 27/06/2016
Contact:
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Results
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Results available:
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Yes |
Date Posted:
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15/04/2021 |
Date Completed:
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04/02/2018 |
URL:
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