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.: PACTR202201730674988 Date of Approval: 17/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PROTOCOL OF A THESIS FOR PARTIAL FULFILMENT OF M.D. DEGREE IN ANESTHESIA
Official scientific title Adductor canal block as an adjuvant in a multimodal analgesia protocol vs. multimodal analgesia alone for total knee arthroplasty
Brief summary describing the background and objectives of the trial The purpose of this study is to determine if the addition of an ACB after spinal anesthesia, as a part of post-operative multimodal analgesia protocol would produce an improvement in post-operative pain , narcotic (morphine) consumption, early ambulation and patient satisfaction.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial postoperative pain managment
Anticipated trial start date 01/12/2021
Actual trial start date
Anticipated date of last follow up 01/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 72
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group adductor canal block none none multimodal analgesic drugs 36 Uncontrolled
Experimental Group adductor canal block 20 ml once A high-frequency linear array ultrasound transducer will be used to identify the adductor canal. The transducer will be placed transverse on the anteromedial thigh at the junction between the middle and distal third of the thigh , local anesthetic spread lateral to the superficial femoral artery and deep to the sartorius muscle. At this level, the hyperechoic structure located lateral/anterior to the artery will be identified as the target site at the adductor canal. A single shot ACB of 20 mL 0.5% bupivacaine via 22 g short beveled, 4-inch needle will be administered to 36 patients in the ACB group. 36
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Patient who agreed to underwent ACB.  Patient age of 50 -70 yrs old , both genders.  American Society of Anesthesiologists physical status (ASA) Class II-III.  Patient who will agree to undergo Spinal anesthesia for the TKA procedure.  Unilateral total knee arthroplasty.  Patient refusal.  Total knee arthroplasty revision surgery.  Prior knee surgery.  ASA class > III.  Contraindication to spinal or regional anesthesia.  Narcotic allergies as morphine.  Allergy from local anesthetics.  Coagulopathy. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 70 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 28/09/2020 research ethics committee
Ethics Committee Address
Street address City Postal code Country
cairo abbasia cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome post-operative pain , narcotic (morphine) consumption 0 6 12 24
Secondary Outcome early ambulation and patient satisfaction. 6 12 18 24
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assembled operating theater at Ain Shams University Hospitals. abasya el demrdash cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Radwa khairy Fifth settelment Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ain shams univeristy el demrdash cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator radwa khairy radwakhairy51219@gmail.com 01152821191 new cairo
City Postal code Country Position/Affiliation
cairo Egypt assisstant lecturere
Role Name Email Phone Street address
Scientific Enquiries sanna mohamed sana_y_fawal@yahoo.com 01143504178 cario
City Postal code Country Position/Affiliation
cairo Egypt prof
Role Name Email Phone Street address
Public Enquiries yasmine hassan yassminhassan7@gmail.com 01095140964 cairo
City Postal code Country Position/Affiliation
cairo Egypt lecturere
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes yes , Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices will be shared with Anyone who wishes to access the data , for any purpose, Data are available indefinitely at (Link to be included), Immediately following publication, No end date, Study protocol, Statistical Analysis Plan,. Informed Consent Form,Statistical Analysis Plan,Study Protocol one year adductor canal block multimodal analgesia
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 26/12/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information