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.: PACTR202305870625335 Date of Registration: 09/05/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Combined Adductor Canal and Infiltration in the Space between Popliteal Artery and Posterior Capsule of the Knee Blocks (IPACK) Versus Combined Genicular Nerve Block and Infiltration in the Space between Popliteal Artery and Posterior Capsule of the Knee Block (IPACK) in Total Knee Arthroplasty.
Official scientific title Combined Adductor Canal and Infiltration in the Space between Popliteal Artery and Posterior Capsule of the Knee Blocks (IPACK) Versus Combined Genicular Nerve Block and Infiltration in the Space between Popliteal Artery and Posterior Capsule of the Knee Block (IPACK) in Total Knee Arthroplasty.
Brief summary describing the background and objectives of the trial Optimal postoperative knee analgesia is important for not only patient comfort and satisfaction, but also for accelerating mobilization, functional recovery, and hospital discharge. Multimodal analgesia and motor-protective blocks are increasingly used to facilitate early ambulation and provide superior performance . The comparison of combined ACB and IPACK blocks versus combined GNB and IPACK blocks as analgesia for TKA is currently lacking in the anaesthesia literatures, thus this study compares the combination of ACB with IPACK blocks versus the combination of GNB with IPACK blocks regarding providing superior analgesia and limiting motor weakness. Also improving postoperative pain score, ambulation, and oral morphine equivalents
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 Prevention
Anticipated trial start date 01/11/2022
Actual trial start date 01/01/2023
Anticipated date of last follow up 30/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet 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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Adductor canal block combined with IPACK block Adductor canal block (ACB) by10ml 0.25% Bupivacaine and IPACK block by 20 ml 0.25% Bupivacaine (not exceeding toxic dose of Bupivacaine 2 mg/kg) 15 mins. After spinal anaesthesia patients will be positioned in supine position, an ultrasound guided adductor canal block will be performed at mid-thigh level, lateral to the femoral artery, and deep to sartorius muscle using a high frequency linear ultrasound transducer (10–12 Hz; Sono-Site Turbo; SonoSite Inc., Bothell, WA), as described by Manickam in 2009 . 10 mL of 0.25% bupivacaine will be injected after negative aspiration under sterile conditions. After the knee being flexed, the probe will be placed in the popliteal region, and the popliteal artery will be identified. The ultrasound probe will be moved distally from the division of the common peroneal and tibial nerves. The probe will be slowly moved towards the popliteal crease until the tibial nerve is defined superficially to the popliteal vessels. The ultrasound probe will be moved to the level of the junction of the femoral condyles with the femoral shaft. Popliteal artery, tibial and peroneal nerves will be visualized and the space between the femur and popliteal artery will be determined. A 20Gauge × 120 mm needle will be advanced to this area called IPACK using the lateral to medial in-plane technique. After negative aspiration, 20 ml of 0.25% bupivacaine will be injected incrementally while the needle will be slowly withdrawn until the end of the lateral femoral condyle under sterile conditions . 20 Active-Treatment of Control Group
Experimental Group Genicular nerve block combined with IPACK block (GNB) using a total of 15 ml 0.25% Bupivacaine in equal increments at multiple site (5ml for each genicular nerve) and IPACK block using 20 ml 0.25% Bupivacaine (not exceeding toxic dose of bupivacaine 2 mg/kg) 15 mins. After spinal anaesthesia patients will be positioned in supine position, an ultrasound guided genicular nerve block will be performed as the ultrasound transducer will be placed parallel to the femur shaft and the epicondyle will be identified. The superolateral, superomedial, and inferomedial genicular arteries, which follow a similar route with their each genicular nerve will be visualized close to the periosteal areas. A 20G needle x120mm needle will be directed in the plane of the ultrasound probe in the long-axis view. After confirming the placement of the needle-tip next to a genicular artery, the superior lateral, superior medial, and inferior medial genicular nerves will be given a total amount of 15 mL local anaesthetic of 0.25% bupivacaine in equal increments at multiple sites. The injection points were previously described by Qudsi-Sinclair et al in 2017(21). Then IPACK block will be performed After the knee being flexed, the probe will be placed in the popliteal region as previously described in group (ACB+IPACK). 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- American Society of Anaesthesiologists (ASA) physical status I–III. - Patients between the ages of 18 and 80 years. - Patients undergoing primary unilateral knee arthroplasty. - Both sexes. - BMI ≤ 40 - Patient’s refusal to be enrolled in the study. - Bilateral TKA or previous surgery on the same knee. - Allergy to one of the study drugs. - Chronic use of gabapentin/pregabalin. - History of Arrhythmia, seizures or sepsis Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 17/10/2022 Research Ethics Committee of faculty of medicine asu
Ethics Committee Address
Street address City Postal code Country
Abbasya Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - Time to the first rescue analgesic dose by assessing postoperative pain using NRS 48 hours postoperative
Secondary Outcome - The total amount of Nalbuphine consumption , Hemodynamic changes ,The patient’s first mobilization time will be recorded in hours, Timed Up and Go (TUG test), side effects of nerve blocks and the length of hospital stay 48 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Ainshams University Abbasya Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sara Magdy Abdelrhman Elkfafi Faculty of Medicine-ASU-Abbasia - Cairo cairo 11591 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sara Magdy Abdelrhman Elkfafi faculty of medicine ASU abbasya street cairo 11591 Egypt self-funded
COLLABORATORS
Name Street address City Postal code Country
Mahmoud Abdelaziz Ahmed Ghallab Faculty of medicine, asu ,Abbasya cairo 11591 Egypt
Hazem Mohamed Abdelrhman Fawzy Faculty of Medicine , ASU, Abbasya Cairo 11591 Egypt
Ghada Mohamed Samir Elsaeid Faculty of Medicine , ASU, Abbasya Cairo 11591 Egypt
Reham Mustafa Hashim Kotb Faculty of Medicine , ASU, Abbasya cairo 11591 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Dr. Mahmoud Abdelaziz Ahmed Ghallab mghallab62@gmail.com 01221625868 faculty of Medicine-ASU-Abbasya
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Professor of Anesthesia and ICU and Pain management
Role Name Email Phone Street address
Scientific Enquiries Dr. Hazem Mohamed Abdelrhman Fawzy hazemmfawzi@yahoo.com 01001771433 Faculty of Medicine-ASU-Abbasya
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Professor of Anesthesia and ICU and Pain management
Role Name Email Phone Street address
Principal Investigator Ghada Mohamed Samir Elsaeid Dr.ghada216@gmail.com 01005043691 Faculty of Medicine-ASU-Abbasya
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Assistant Professor of Anesthesia and ICU and Pain management
Role Name Email Phone Street address
Public Enquiries Reham Mustafa Hashim Kotb Dr_reham80@yahoo.com 01003072065 Faculty of Medicine-ASU-Abbasya
City Postal code Country Position/Affiliation
cairo 11591 Egypt Assistant Professor of Anesthesia and ICU and Pain Management
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data will be collected during the trial, after deidentification Study Protocol non-applicable non-applicable
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 URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information