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.: PACTR202305731865991 Date of Approval: 09/05/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between Ultrasound Guided Femoral Nerve Block versus IPACK Block (Interspace between the Popliteal Artery and Capsule of the Posterior Knee) in patients Undergoing Total Knee Replacement on Postoperative Ambulation and Pain .
Official scientific title Comparison between Ultrasound Guided Femoral Nerve Block versus IPACK Block (Interspace between the Popliteal Artery and Capsule of the Posterior Knee) in patients Undergoing Total Knee Replacement on Postoperative Ambulation and Pain .
Brief summary describing the background and objectives of the trial Total knee replacement (TKR) is a well-known popular surgical procedure for knee diseases, including end-stage knee osteoarthritis that causes severe postoperative pain and prolonged immobility. TKR is associated with significant postoperative pain. The need for effective analgesia without compromising function is a priority. The current study aims to assess the IPACK block concerning postoperative ambulation as a primary outcome and analgesic efficacy as a secondary outcome when compared with femoral nerve block following TKR.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 13/09/2022
Actual trial start date 15/09/2022
Anticipated date of last follow up 01/02/2023
Actual Last follow-up date 01/04/2023
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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 Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IPACK 20ml bupivacaine (0.25%) was given to patients post spinal anesthesia follow up for 24 h postoperative IPACK will be performed in the study after the injection of spinal anesthesia and before the beginning of surgery. IPACK will be performed under complete aseptic precautions using an ultrasound machine with high-frequency linear probe covered with a sterile sheath (Sonoscape® SSI 6000, China with a 12-6 MHz high-frequency linear probe) and 100 mm needle SonoPlex (B- Braun Medical Inc., Bethlehem, PA, USA). IPACK block is performed while the patient is in a supine position with slight knee flexion, the probe will be applied to the popliteal fossa for identification of the popliteal artery and femur. Then, the probe will be distally slid for revealing the two femoral condyles followed by proximal sliding of the probe until the humps of the femoral condyles disappeared and the flat metaphysis appeared. A needle will be advanced from the lateral aspect and directed across the space between the popliteal artery and femur and once the needle 20
Control Group Femoral nerve block 20ml bupivacaine (0.25%) was given to patients post spinal anesthesia 24 h postoperative FNB will be performed in the study after the injection of spinal anesthesia and before the beginning of surgery. FNB will be performed under complete aseptic precautions using an ultrasound machine with high-frequency linear probe covered with a sterile sheath (Sonoscape® SSI 6000, China with a 12-6 MHz high-frequency linear probe) and 100 mm needle SonoPlex (B- Braun Medical Inc., Bethlehem, PA, USA). When using ultrasound, the transducer is placed transversely at the inguinal crease, and the femoral vessels are located. Immediately lateral to the femoral vessels, the femoral nerve classically appears as a hyperechoic wedge or ovoid structure. Once the femoral nerve and relevant neighboring structures have been identified, the needle tip is advanced below the fascia iliaca towards the femoral nerve. Confirming negative aspiration before injection to avoid intravascular injection. The ultrasound monitor will show the spreading of local injection around the nerve. After negative aspiration, 20 ml of 0.25% bupivacaine will be injected. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Elective unilateral TKR under spinal anesthesia. Patients aged between 40 and 85 years. American Society of Anesthesiologists (ASA) physical status classification I –III. Both sexes. Contraindication for neuraxial anesthesia or nerve block (bleeding diathesis, pre-existing lower extremity neuromuscular disorder, local infection, or sepsis). Allergy or contraindication to the drugs used in the study (local anesthetic, NSAIDs, opioids). Declining to give written informed consent. Psychiatric disorder. American Society of Anesthesiologists (ASA) Physical Status Class IV and more. 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 85 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 12/09/2022 FMASU M5 5912022
Ethics Committee Address
Street address City Postal code Country
Abbasia,Cairo Cairo 0000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assessment of ambulation as determined by timed up and go test (TUG) that measures the time needed by the patient to stand from sitting position, walk 3 meters, turn around, walk back to the chair and sit down. The patient had one trial and the test was considered passed if the score was less than three minutes and 30 seconds. 10-min walk test that measures the time needed by the patient to walk 10 meters. These tests were only performed if the patient feels that it was possible to rise and walk without the risk of falling and both tests were done twice on the first-day post-operative every 12 hours. 24 hours
Secondary Outcome 1-The visual analogue scale (VAS) for pain used to assess the postoperative pain was evaluated postoperatively and every 2 hours during the first 6 hours and then every 6 hours there for the remaining 24 hours postoperatively. 2- Total dose of rescue analgesic consumption every 12 h post operative for the first 24 h. 3- Heart rate and mean arterial blood pressure were assessed every 2 hours during the first 6 hours and then every 6 hours there for the remaining 24 hours postoperatively. 24 hours post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals Abbasia, Cairo Cairo 0000 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams univeristy Abbassia Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Eldemerdash hospitals Abbasia,Cairo Cairo 000 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdelrahman Atef Atef abdelrahmanatef319@gmail.com +0201091541157 Cairo,Egypt
City Postal code Country Position/Affiliation
Cairo Egypt Anesthesia resident
Role Name Email Phone Street address
Scientific Enquiries Sherif Sultan sherif_sultan@yahoo.com +0201128448448 Cairo
City Postal code Country Position/Affiliation
Cairo Egypt professor of Anesthesia
Role Name Email Phone Street address
Public Enquiries Mostafa Mansour mostafa.mansor@med.asu.edu.eg +0201093322145 Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Associate professor of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual partiticipant data collected during trial, after deidentification ( including text, tabels, figures and appendices); Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Patient informed written consent, and ethical committee approval of Faculty OF Medicine; Ain Shams University were obtained before patient allocation approval n. MS 591/2022. Anyone who wishes to access data for any type of analysis. The data are avilable in our university data warehouse .
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 09/05/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 09/05/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information