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.: PACTR202301536928551 Date of Approval: 23/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Adding Infiltration between The Popliteal Artery and Capsule of The Knee Block (IPACK) to Continuous Adductor Canal Block after Total Knee Arthroplasty
Official scientific title Effect of Adding Infiltration between The Popliteal Artery and Capsule of The Knee Block (IPACK) to Continuous Adductor Canal Block after Total Knee Arthroplasty
Brief summary describing the background and objectives of the trial Our study objective is to determine the the efficacy of posterior knee block, known as the Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) block added to Continuous Adductor Canal Block (CACB) after total knee arthroplasty as regards potoperative pain control, total naluphine consumption and motor power. The study is a randomized, prospective, comparative study where 52 patients subjected to knee surgeries were randomized into two groups, one of them received ultrasound guided Continuous Adductor canal block only, while the other group of patients received a combined Continuous adductor canal block and IPACK block at the start of surgery. Regarding pain control data in terms of VAS score at intervals of 2,4,8,12,16, and 24 hours and nalbuphine consumption in 1st 24 hours there was statistically significant difference between groups except at 16 and 24 hours. When demographic information such age, sex, BMI and ASA scores were examined between the two groups, there was no statistically significant difference between them (p-value > 0.05). Additionally, there was no statistically significant difference between groups in terms of onset of ambulation, TUG test and straight leg raising test.
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 01/09/2021
Actual trial start date 20/09/2021
Anticipated date of last follow up 01/11/2022
Actual Last follow-up date 17/11/2022
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants) 52
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group CACB group 30 ml of 0.25% bupivacaine will be administered as a bolus injection with US guidance. A 21-gauge catheter will be placed in adductor canal with US guidance and 125 ml of 0.125% bupivacaine infusion will be given 5 ml/h for 24 h with a continuous infusion set 24 hours The probe will be located at the mid-thigh level (approximately halfway between the anterior superior iliac spine and the patella). A 10 cm, 18-gauge needle will be introduced in plane, through the sartorius muscle. Correct position for the tip of the needle in adductor canal will be checked with an injection of 10 ml saline. In all patients then 30 ml of 0.25% bupivacaine will be administered as a bolus injection with US guidance. A 21-gauge catheter will be placed in adductor canal with US guidance and 125 ml of 0.125% bupivacaine infusion will be given 5 ml/h for 24 h with a continuous infusion set 26 Active-Treatment of Control Group
Experimental Group IPACK added to CACB group 20 ml of 0.25% bupivacaine incrementally over 2 minutes Added to CACB group the leg will be positioned with the knee flexed and hip externally rotated. A high-frequency ultrasound transducer will be used to visualize the popliteal artery and posterior surface of the distal femur. If the femoral condyles were seen, the transducer will be moved proximally to a position over the distal femoral shaft. Using an in-plane approach, A 10 cm, 18-gauge needle will be inserted from medial to lateral to position the needle tip between the popliteal artery and the femur. 20 ml of 0.25% bupivacaine will be injected incrementally into this space 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients scheduled for elective total knee arthroplasty Between the age of (21-65) years Of both sexes , Physical Status Class I to II American Society of Anesthesiologists (ASA) With successful spinal anesthesia Declining to give written informed consent. History of allergy to the medications used in the study. Contraindications to regional anesthesia (including coagulopathy and local infection). Polytrauma patients having lower limb fractures. Patients with pre-existing myopathy or neuropathy on the operating limb. Patients with diabetes mellitus. Psychiatric disorder. Morbid obesity (BMI: > 45kg/m2) Complicated Surgery. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 65 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 18/08/2021 Research Ethics committee at the faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
38 Abbassia, Next to the Al-Nour Mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome comparison of postoperative pain during movement using the Visual Analogue Scale (VAS) score between the two groups 2,4,8,12,16 and 24 hours postoperatively
Secondary Outcome The postoperative opioid consumption 24 hours postoperatively
Secondary Outcome the functional recovery including straight leg rise, range of motion and onset of ambulance 24 hours postoperatively
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, Egypt Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The principal investigator 289 south academy 1st settlement new cairo Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain shams university 38 Abbassia, Next to the Al-Nour Mosque Cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hatem Mohammed 289 south academy 1st settlement new cairo cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hatem Abdo hatemc3@hotmail.com +201009914784 289 soth academy 1st Settlemennew cairo
City Postal code Country Position/Affiliation
Cairo Egypt Assistant lecturer department of anesthesia faculty of medicine Ain shams university
Role Name Email Phone Street address
Public Enquiries Diaaeldein Haiba diaaeldein@med.asu.edu.eg +201006516286 44 abdelmonem hafez st. almaza
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of anesthesia faculty of medicine Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Amr Kassem amrkasem240@gmail.com +201005282224 Mahkama square , heliopolis
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor of anesthesia faculty of medicine Ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of individual participant data collected during the trial, after deidentification 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