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.: PACTR202308887289470 Date of Approval: 07/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Comparative Study between Adductor Canal Block and IPACK Block vs ACB Alone vs IPACK Alone after Total Knee Arthroplasty for Post Operative Pain and Mobility
Official scientific title A Comparative Study between Adductor Canal Block and IPACK Block (Interspace between Popliteal Artery and the Capsule of Posterior Knee) vs ACB Alone vs IPACK Alone after Total Knee Arthroplasty for Post Operative Pain and Mobility
Brief summary describing the background and objectives of the trial ACB + IPACK is a promising technique that offers improved pain management in the immediate postoperative period without affecting the motor function around the knee joint resulting in better ROM and ambulation compared to ACB alone and IPACK alone. Adductor canal block (ACB) is a peripheral nerve blockade technique that provides good pain control in patients undergoing total knee arthroplasty which however does not relieve posterior knee pain. The recent technique of an ultrasound-guided local anesthetic infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) has shown promising results in providing significant posterior knee analgesia without affecting the motor nerves In this study we will evaluate the effect of ACB plus IPACK vs ACB only VS IPACK only in patients post unilateral knee arthroplasty on post operative pain and mobility. Aim of This study is aiming to evaluate the effect of ACB plus IPACK vs ACB only VS IPACK only in patients post unilateral knee arthroplasty on post operative pain and mobility. To minimize the usage of total dose of narcotics postoperative
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 Pain management
Anticipated trial start date 01/05/2022
Actual trial start date 31/05/2022
Anticipated date of last follow up 30/11/2022
Actual Last follow-up date 20/12/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Closed to recruitment,follow-up continuing
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Adductor canal block 20 ml of 0.5% bupivacaine was injected Immediately after surgery and followed up for 24 hours ACB in the immediate postoperative period under a high-frequency ultrasound guidance (SonoSite™, Inc., Bothell, WA 98021, USA) in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.5% bupivacaine was injected in the canal using a 22-gauge 100-mm short-beveled regional block needle (Stimuplex® insulated B Braun Medical Germany). 20
Experimental Group IPACK 15 ml of 0.5% bupivacaine was injected. Immediately after surgery and followed up for 24 hours IPACK block in which the patient was placed in a supine position and knee was placed in position of 90° flexion. A low-frequency ultrasound probe was positioned in the popliteal crease, and spinal needle was inserted from medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle was placed 1–2 cm beyond the lateral edge of the artery, and 15 ml of 0.5% bupivacaine was injected. 20
Control Group Adductor canal block and IPACK ml of 0.5% bupivacaine was injected in the canal and 15 ml of 0.5% bupivacaine was injected in IPACK Immediately after surgery and followed up for 24 hours ACB in the immediate postoperative period under a high-frequency ultrasound guidance (SonoSite™, Inc., Bothell, WA 98021, USA) in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.5% bupivacaine was injected in the canal using a 22-gauge 100-mm short-beveled regional block needle (Stimuplex® insulated B Braun Medical Germany). IPACK block in which the patient was placed in a supine position and knee was placed in position of 90° flexion. A low-frequency ultrasound probe was positioned in the popliteal crease, and spinal needle was inserted from medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle was placed 1–2 cm beyond the lateral edge of the artery, and 15 ml of 0.5% bupivacaine was injected. 20 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 50-70 years, Unilateral-total knee arthroplasty, all patients who will receive spinal anesthesia. Patients undergoing bilateral or revision total knee replacement, history of bleeding diathesis, prior vascular surgery on femoral vessels on operated site, severe renal insufficiency (GFR<50), History of seizures or sepsis, Pre existing lower extremity neurological abnormalities, patients suffering from mental or psychological disorders. 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 26/12/2021 Research Ethics committee
Ethics Committee Address
Street address City Postal code Country
Abbasia cairo Egypt Cairo 11511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative pain at rest was the primary outcome measure which was assessed using the visual analog scale (VAS) (scale 0–10, where 0 = no pain and 10 = worst imaginable pain). Pain assessment by VAS score was explained to all the patients before surgery and taught the VAS score for self-assessment of pain at the time of enrollment for the study and to the nurse staff attending the patients. Post operative pain at rest was assessed by VAS score of scale from 0-10 and was recorded at 24 h after surgery. 24 hours post operative
Secondary Outcome measured time to mobility after surgery and total dose of rescue analgesia given and was observed by another anesthesiologist. 24 hours post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals El-Khalyfa El-Mamoun Street Abbasya, Cairo , Eygpt Cairo 11588 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded Heliopolis Cairo 11511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain shams university hospitals El-Khalyfa El-Mamoun Street Abbasya, Cairo , Eygpt Cairo 11588 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Mohamed Zaghloul Mohamed_zaghloul@hotmail.com +201140077888 New cairo
City Postal code Country Position/Affiliation
Cairo Egypt Professor of anesthesia and ICU Ain shams university
Role Name Email Phone Street address
Principal Investigator Karim Kamal Karimykhakim@hotmail.com +201222487007 New cairo
City Postal code Country Position/Affiliation
Cairo Egypt Professor of anesthesia and ICU Ain shams university
Role Name Email Phone Street address
Public Enquiries Fady Abdel Malek Fady_adib@yahoo.com +201011777037 New cairo
City Postal code Country Position/Affiliation
Cairo 11511 Egypt Assistant professor of anesthesia and ICU Ain shams university hospitals
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data collected during trial after identification Statistical Analysis Plan Following publication Any purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
URL 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