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.: PACTR202312862501046 Date of Approval: 22/12/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Comparative study between the analgesic effect of Adductor Canal Block with IPACK Block (Interspace between Popliteal Artery and the Capsule of the Posterior Knee) and the analgesic effect of Adductor Canal Block alone after total knee arthroplasty
Official scientific title A Comparative study between the analgesic effect of Adductor Canal Block with IPACK Block (Interspace between Popliteal Artery and the Capsule of the Posterior Knee) and the analgesic effect of Adductor Canal Block alone after total knee arthroplasty
Brief summary describing the background and objectives of the trial Acute postoperative pain after total knee arthroplasty (TKA) is so severe to the degree that necessitates proper analgesia which is one of the patients' human rights and prevents the drawbacks of pain on various body systems. Local anesthetic Infiltration between the Popliteal Artery and the Capsule of the Knee (IPACK) can represent a promising technique for management of postoperative pain in combination with adductor canal block (ACB) after TKA The aim of this prospective study is to evaluate the efficacy of IPACK in combination with ACB in relieving postoperative pain after TKA, particularly posterior knee pain, considering that this technique is relatively new and there are not many studies about evaluating this technique for this purpose, compared to opioid analgesics after spinal anesthesia alone or ACB alone.
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 Treatment: Drugs
Anticipated trial start date 14/02/2023
Actual trial start date 20/02/2023
Anticipated date of last follow up 20/11/2023
Actual Last follow-up date 20/11/2023
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group spinal anesthesia with Adductor canal block only 3ml 0.5% hyperbaric bupivacaine at the L3/4 interspaces without any additives.in spinal anesthesia 15 ml of 0.25%bupivacaine for adductor canal block All patients will be given spinal anesthesia with 3ml 0.5% hyperbaric bupivacaine at the L3/4 interspaces without any additives. Patient will then lie supine and monitoring adequate level of anesthesia together with hemodynamics stability will be checked all through the operation. Single injections for adductor canal block 10-20 minutes just before the skin incision patient will be prepared for spinal anesthesia , in sitting position under complete aseptic technique. - Skin local infiltration using 3ml lidocaine 2% will be done first, then spinal needle 25G will be used. All patients will be given spinal anesthesia with 3ml 0.5% hyperbaric bupivacaine at the L3/4 interspaces without any additives. Patient will then lie supine and monitoring adequate level of anesthesia together with hemodynamics stability will be checked. Ultrasound-guided Adductor canal block will be performed to patients in the supine position under complete aseptic conditions. A high frequency (6-15MHz) linear probe of ultrasound machine (Sonosite Edge II) will be positioned at the point midway between the anterior superior iliac spine and the upper pole of the patella. The adductor canal will be located as a hyperechoic structure beneath the sartorius muscle and after skin infiltration with 2ml of lidocaine 1%, a spinal needle 22G x 3.5 inches will be advanced with the guidance of ultrasound in an in-plane technique and bupivacaine 0.25% 15ml will be injected (not exceeding toxic dose of bupivacaine 2.5mg/kg). 30 Active-Treatment of Control Group
Experimental Group Patients will recieve adductor canal block followed by IPACK block before total knee arthroplasty bupivacaine 0.25% 15ml will be injected incrementally . (Not exceeding toxic dose of bupivacaine 2.5mg/kg). single injection 10-20 minutes just before the skin incision - After skin infiltration with 2ml of 1% lidocaine, a spinal needle 22G x 3.5 inches will be advanced , with the guidance of ultrasound in an in-plane technique ,from the lateral aspect and directed across the space between the popliteal artery and femur and once the needle reaches the medial edge of the femur, nearly at the level of the popliteal artery, negative aspiration will be confirmed and bupivacaine 0.25% 15ml will be injected incrementally as the needle is withdrawn. (Not exceeding toxic dose of bupivacaine 2.5mg/kg). - Intraoperative, heart rate, blood pressure, SpO2, and respiratory rate will be measured and recorded every 5 minutes. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
▪ No sex predilection. ▪ Age group: ranges from 45 to 60 years ▪ Physical Status: ASA I , II and III (controlled) patients after taking written and informed consent ▪ Subjected to unilateral total knee arthroplasty. ▪ Refusal of procedure or participation in the study by patients. ▪ Physical status: ASA IV or above ▪ Subjects presenting with allergy to local anesthetics, alcohol or drug abuse. ▪ Inability to cooperate ▪ Neuromuscular pathology ▪ Previous trauma or surgery to the leg. ▪ Opioids or steroids intake within the last 4 weeks or any analgesics during the last 48 hours. ▪ contraindications to spinal anesthesia as coagulopathies and severe aortic stenosis Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 60 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 08/01/2023 Reserch Ethical Committee at Fculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38 Abbassia Square,next to Al Nour Mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ● Measuring post operative pain by using Visual Analog Scale (VAS) in the first 24 hours postoperative of the study ● Time recorded for first rescue analgesia which is defined as the time after finishing the block till the patient’s first analgesic requirement postoperative in the ward. from the start of the block till the patient first analgesic requirement
Secondary Outcome ● Total opioides (pethidine) consumption. ● Range of motion and ambulation distance assessed by the number of steps walked by the patient after the end of effect of spinal anesthesia given. from the time block given till 24 hrs postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Ain Shams University 38 Abbassia Square, Next to Al-Nour Mosque Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
the principle investigator 11 engeneers buildings,infront of first police station,nasr road,nasr city cairo 11765 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine .ain shams university abbasia cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Marina Mohsen Nemr 11 Engineers buildings,infront of first police station,nasr road,nasr city cairo 11765 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Ragheb dr_ragheb100@hotmail.com 01002987138 abbasia
City Postal code Country Position/Affiliation
cairo 11591 Egypt Lecturer of Anesthesia.Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Public Enquiries Marina Mohsen marina.mohsen@med.asu.edu.eg 01002090825 11 engeneers buildings infront of first police station ,Nasr Road,Nasr City
City Postal code Country Position/Affiliation
Cairo 11765 Egypt Assistant Lecturer in departement of Anesthesia Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mostafa ahmadabdulmageed@gmail.com 01000560552 abassya
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer in the departement of Anesthesia.Faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual data collected during the trial, after de-identification Study Protocol Following publication Any purpose
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