Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201907788767332 Date of Approval: 03/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Adductor Canal Block Versus Femoral Nerve Block in Unicompartmental Knee Arthroplasty: A Randomized, Prospective, Comparative Study
Official scientific title Adductor Canal Block Versus Femoral Nerve Block in Unicompartmental Knee Arthroplasty: A Randomized, Prospective, Comparative Study
Brief summary describing the background and objectives of the trial knee arthroplasty (KA) involves extensive bone resection and soft tissue manipulation, and patients can experience severe pain during the early postoperative period. Appropriate pain management after KA allows for faster recovery, reduces the risk of postoperative complications, and improves patient satisfaction1. Contemporary pain management regimens following KA include oral analgesics, periarticular injection, peripheral nerve blocks (PNBs), and intravenous patient-controlled analgesia2. As PNBs provide effective and synergistic pain relief when used as part of a multimodal regimen, they are considered to be an essential part of the current multimodal pain management protocol following KA3. Unicompartmental knee arthroplasty had varying degrees of acceptance since it was introduced 3 decades ago. However, after recognizing the need to avoid overcorrection of the mechanical axis, surgeons were able to reduce the risk that pain in the '' normal '' compartment would cause early failure4.with the publication of recent studies reporting 10 years survival rates exceeding 93% together with the introduction of the mobile bearing form of the procedure. Thus, Enthusiasm for UKA increased again4-5.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) UKA Adductor CaNAL
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 20/02/2019
Actual trial start date 02/03/2019
Anticipated date of last follow up 30/06/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Fomoral Nerve Group (30 ccs of 0.25% of bupivacaine with 5 μg/ml epinephrine, via a 22-gauge 2-inch Stimuplex A needle; B. Braun Medical Inc.) with nerve stimulator, a confirmation will be performed below the inguinal ligament. the study time with nerve stimulator, a confirmation will be performed below the inguinal ligament. The type of motor response (e.g., quadriceps, patellar) and the minimum current needed will be recorded. Ultrasound pictures (preinjection and postinjection) will be obtained to verify proper local anesthetic placement. 30 Active-Treatment of Control Group
Experimental Group Aductor canal group 20cc of 0.5% of bupivacaine with 5 μg/ml epinephrine, the study time via a 21-gauge 4-inch Stimuplex A needle; B. Braun Medical Inc., Melsungen, Germany) will be performed at mid-thigh level using a high-frequency linear ultrasound transducer (10–12 Hz; SonoSite Turbo; SonoSite Inc., Bothell, WA), as described by Manickam.12 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Elective Unilateral (UKA). • Either Sex aged 18-90 years. • Planned combined spinal-epidural anesthesia (CSE). • ASA ǀ &ǁ &ǁǀ. • Contraindications to for neuraxial blockade. • Chronic opioid use (defined as daily or almost daily use of opioids for >3 months). • Hypersensitivity and/ or allergies to local anesthetics. • Preexisting neuropathy on the operative limb. • contraindications to a femoral or ACB, allergy to any of the study medications, • Absolute or relative contraindications to (UKA) e.g. inflammatory arthropathy, previous high tibial osteotomy (HTO) with overcorrection, cruciate ligament lesion, medial or lateral subluxation and tibial or femoral shaft deformity.9 Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/03/2019 Fayoum University Ethical Committee
Ethics Committee Address
Street address City Postal code Country
University Province Fayoum 63514 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome NRS numerical rated scale at 6,8 ,24,48 hours
Secondary Outcome Quadriceps muscle strength. 6,8 ,24,48 hours
Secondary Outcome total opioid consumption iv . 1st 48 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals Ramsis Street Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
our resources 105 toman bai street, Zeitoun , Cairo Cairo 11321 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Hospitals Ramsees Cairo 11566 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Joseph Makram botros 105 Toman Bai street , Zeitoun Cairo 11321 Egypt
Simon Haleem Armanios El Higaz Street, Heliopolis Cairo 11757 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joseph Botros dr_jo27@yahoo.com 01227598825 105 Toman Bai Street
City Postal code Country Position/Affiliation
Cairo 11321 Egypt Fayoum University Hospitals
Role Name Email Phone Street address
Public Enquiries Joseph Botros dr_jo27@yahoo.com 01227598825 105 Toman Bai Street , Zeitoun
City Postal code Country Position/Affiliation
Cairo 11321 Egypt Fayoum University Hospitals
Role Name Email Phone Street address
Scientific Enquiries Simon Armanios simon_dr_106@hotmail.com 01002864104 Elhigaz street
City Postal code Country Position/Affiliation
Cairo 11757 Egypt Ain Shams University Hospitals
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all collected IPD sets underlie results in a publication are to be shared. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol After the end of the study. 31-07-2019 by e-mails of the collaborators, Joseph Makram Botros, and Simon Halim Armanios. URL of the Study. The Anesthesiology department of Ain Shams University.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not yet determined No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information