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.: PACTR202204592395672 Date of Approval: 19/04/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Postoperative Analgesic Efficacy of Ultrasound Guided Combined Femoral - Sciatic Nerve Block versus Combined Adductor canal block – IPACK Block in Patients Undergoing Total Knee Arthroplasty
Official scientific title Postoperative Analgesic Efficacy of Ultrasound Guided Combined Femoral - Sciatic Nerve Block versus Combined Adductor canal block – IPACK Block in Patients Undergoing Total Knee Arthroplasty
Brief summary describing the background and objectives of the trial Optimal pain control in patients undergoing total knee arthroplasty (TKA) is imperative for good rehabilitation and functional outcomes. Current modalities in use aim at reducing postoperative opioid consumption to control postoperative pain thus minimizing its complications in what is recently known as multimodal analgesia techniques. As a result, newer pain control modalities have been used providing adequate pain relief and not affecting muscle strength. Peripheral nerve blocks were introduced as an excellent solution for multimodal analgesia peri-operatively. We have designed this study to assess postoperative analgesic efficacy, time needed to experience breakthrough pain, the total amount of postoperative analgesic used, and performance during physical therapy in patients undergoing TKA.
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 01/09/2021
Actual trial start date 01/11/2021
Anticipated date of last follow up 31/01/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 femoral nerve block and sciatic nerve block 20 mL of bupivacaine 0.25% 15 min The ultrasound scan for femoral nerve by using linear transducer(13-6 MHz) mid-point inguinal ligament 2cm caudally, cephalic direction at 30–45° angle, the femoral nerve will be visualized in transverse section 1.5–2 cm lateral to the Common Femoral Artery (CFA), a hyperechoic triangle formed by the fascia iliaca superiorly, Common Femoral Artery and iliopsoas muscle will be demonstrated, where the femoral nerve fibers are located, inserting 22-gauge needle in plane technique till reach this triangle, lateral to the femoral artery. For sciatic nerve block patients are turned to lateral position with the side to be blocked uppermost, with slightly flexion of the hip and knee, under all aseptic precautions, ultrasound scan will be performed using (5-2 MHz )curvilinear transducers. After identifying the greater trochanter and the ischial tuberosity, a line will be drawn between these two landmarks, and the ultrasound probe will be positioned parallel to the line previously drawn with directed laterally. The sub-gluteal space will be seen as a hypoechoic area between the hyperechoic shadows of the gluteus maximus and quadratus femoris muscles. At this level, the sciatic nerve will be visualized as oval hyperechoic nodule within the subgluteal space. At this view spinal needle will be inserted in the plane of the ultrasound beam and will be advanced toward the sciatic nerve in real-time 30 Active-Treatment of Control Group
Experimental Group ultrasound guided Adductor Canal and IPACK block 20 mL of bupivacaine 0.25% 15 min For adductor canal block: while patients in supine position with knee slightly flexed and leg externally rotated (frog-leg position), under all aseptic precautions. The ultrasound scan in ACB will be performed using linear transducer (13-6 MHz) at the mid-point between the inguinal crease and medial condyle. Identify the femur (usually at a depth of 3–5 cm) and sartorius muscle (trapezoid/ boat-shaped) the femoral artery lies under this muscle in the adductor canal. The saphenous nerve usually appears at this position lateral to the artery as a hyperechoic structure. The block needle will be inserted in the plane in a lateral-to-medial orientation and advanced towards the femoral artery from the lateral side of the transducer, through the sartorius muscle, with the tip of the needle placed lateral to the artery . For IPACK block: patient in supine position with knee slightly flexed and leg externally rotated (frog-leg position), clean the area with alcohol swap then will scan the popliteal fossa using a linear (6 -13 MHz) US probe at or proximal to the popliteal crease until the femoral condyles visualized. The US probe then proximally aligned until the condyles disappear and the shaft of the femur visible (interrupted hyperechoic line of the condyles changes to a continuous, hyper-echoic silhouette of the femoral shaft just cranial to the condyles . At this level, the block needle will be inserted in plane in the medial thigh using an anteromedial to posterolateral direction between the popliteal artery and the femur until the needle tip 1 cm beyond the lateral edge of the popliteal artery(the needle tip not be pushed 2 cm beyond the lateral edge of the popliteal artery to avoid anesthetizing the common peroneal nerve and causing a foot-drop 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Patients Age between 18 to 80years old. 2-Physical status I,II according to American association of anaesthesiologists (ASA) score undergoing elective total knee arthroplasty under general anesthesia . 1-Patients refusal. 2-ASA III or above. 3-history of previous open knee surgery. 4-Pre-existing lower extremity neurological abnormality. 5-presence of nearby infection. 6-history of Psychiatric illness. 7-history of drug abuse or allergies to drugs used. 8-any complication of nerve blocks techniques. Adult: 19 Year-44 Year,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 17/04/2021 research ethics committee at the faculty of medicine ain shams univeristy
Ethics Committee Address
Street address City Postal code Country
abbasia cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total dose of rescue analgesia (nalbuphine 5mg ) used in the 1st 24hrs post operative . 24 hours post operative
Secondary Outcome • Modified bromage scale that assess ability to start physical rehabilitation that will be done for extensor group of knee joint, flexors and extensors of ankle joint. • Pain intensity assessment by VAS during rest. • Hemodynamic parameters (MBP, HR) at same time interval of pain assessment. • Adverse effects [sedation , nausea, vomiting]. 24 hours post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams univeristy abbasia cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed sabry El. abbasyia Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mohamed sabry abdelbadie abbasia cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ayman Ahmad Elsayed Abdellatif abbasia cairo 11591 Egypt
Rania Maher Hussien abbasia cairo 11591 Egypt
Tamer Nabil Abdelrahman abbasia cairo 11591 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries ayman Ahmad Elsayed Abdellatif Buayman3@gmail.com 01020166199 abbassia
City Postal code Country Position/Affiliation
cairo 11591 Egypt professor
Role Name Email Phone Street address
Scientific Enquiries Rania Maher Hussien raniamhm.rm@gmail.com 0100054520 abbassia
City Postal code Country Position/Affiliation
cairo 11591 Egypt professor
Role Name Email Phone Street address
Public Enquiries Tamer Nabil Abdelrahman Drtamer.70@gmail.com 01288992910 abbassia
City Postal code Country Position/Affiliation
cairo 11591 Egypt professor
Role Name Email Phone Street address
Principal Investigator mohamed sabry abdel badie drm7md.sabry@gmail.com 01091757431 abbassia
City Postal code Country Position/Affiliation
cairo 11591 Egypt doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be available Study Protocol not applicable not applicable
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