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.: PACTR202312753143536 Date of Approval: 11/12/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Analgesic Efficacy of Ultrasound Guided Anterior Femoral Cutaneous Nerve Block (AFCNB) in Combination with Femoral Triangle Block (FTB) versus Adductor Canal Block (ACB) in Total Knee Arthroplasty (TKA).
Official scientific title The Analgesic Efficacy of Ultrasound Guided Anterior Femoral Cutaneous Nerve Block (AFCNB) in Combination with Femoral Triangle Block (FTB) versus Adductor Canal Block (ACB) in Total Knee Arthroplasty (TKA).
Brief summary describing the background and objectives of the trial Total knee arthroplasty (TKA) is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from knee pain and movement limitation. Adequate analgesia with minimal side-effects allows for early postoperative mobility, optimal functional recovery and decreased postoperative morbidity. Peripheral nerve blocks are effective adjuvant options for pain management for knee arthroplasty. The use of nerve blocks has been proven to be very effective at controlling pain and minimizing narcotic requirements after TKA. In this study, analgesic efficacy of anterior femoral cutaneous nerve block (AFCNB) in combination with femoral triangle block (FTB) will be compared to adductor canal block (ACB) in TKA, both will be done ultrasound guided using 20 ml volume of bupivacaine 0.25% for postoperative analgesia.
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 30/12/2022
Actual trial start date 12/08/2023
Anticipated date of last follow up 30/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Anterior Femoral Cutaneous Nerve Block in Combination with Femoral Triangle Block 20 ml volume of 0.25% bupivacaine divided upon two 10 ml syringes one for each block single injection after administration of spinal anesthesia Anterior femoral cutaneous nerve block (AFCNB): Ultrasound-guided AFCNB will be performed by placing the transducer along the upper to middle third of the thigh. After identifying the position of the superficial femoral artery (SFA) beneath the sartorius muscle (SM) in the ultrasound image, the transducer will be moved slightly cephalad to identify the optimal position of the SFA beneath the medial border of the SM in the ultrasound (Abdallah et al., 2019). After administration of 1−2 ml of 1% lidocaine to anesthetize the skin, an echogenic B-bevel needle will be inserted from the lateral-to-medial direction using an “in-plane technique” and then the needle will be advanced until the needle tip will be superficial to the fascia lata at the junction of the sartorius and rectus femoris muscles (Sogbein et al., 2017). Thereafter, 5 ml of Bupivacaine 0.25% will be slowly injected after careful aspiration while the needle is being advanced superficial to the fascia lata covering the SM until it reaches the medial border of the SM to block the intermediate cutaneous nerve of the thigh (ICNT) (Johnston et al., 2018). The needle will be then redirected to pierce the fascia lata and another 5 ml of bupivacaine 0.25% will be slowly injected after careful aspiration between the fascia lata and SM until the tip of the needle reaches the medial border of the SM to block the medial cutaneous nerve of the thigh (MCNT) (Bjorn et al., 2020). -Femoral triangle block (FTB): The saphenous nerve will be identified by ultrasound and will be seen anterolateral and adjacent to the femoral artery in a short-axis view, approximately ten cm distal to the midpoint of the inguinal ligament inside the femoral triangle and deep to the sartorius muscle. The needle will be inserted in plane with the ultrasound beam through the sartorius muscle. The end point of injection will be peri-arterial spread of local anesthetic around the anterolateral part of the femoral artery to anesthetize the saphenous nerve, the medial vastus muscle nerve, and the medial femoral cutaneous nerve. A 10 ml of bupivacaine 0.25% will be injected incrementally via the needle after careful aspiration. The solution will be seen peri-arterially spreading around the femoral artery (Runge et al., 2020). 30
Control Group Adductor Canal Block 20 ml of 0.25% bupivacaine single injection after administration of spinal anesthesia With the patient supine, and the knee externally rotated and slightly flexed, the ultrasound probe is positioned axially at mid-thigh and femoral artery is visualised. The probe is then moved medially and distally to identify a point between the middle and distal third of the thigh where the artery lies deep to the sartorius and proximal to the adductor hiatus where the saphenous nerve is anterolateral to the artery. The needle is inserted in-plane from lateral to medial till the tip lies superficial to the femoral artery afterward, a 20 ml of 0.25% bupivacaine will be injected (Sogbein et al., 2017). 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a- Physical Status: ASA (American society of Anesthesiologists) I to III. b- Both sexes. c- Aged from forty to eighty years old. d- Scheduled for elective primary total knee arthroplasty due to osteoarthritis under spinal anesthesia. a) Patient`s refusal of the procedure or to participate in the study. b) Patients with major spine deformities preclude spinal anesthesia. c) Patients with bleeding disorders and/or coagulopathy. d) Infection at the injection sites. e) Known allergy to local anesthetics. f) Patients with pre-existing myopathy or neuropathy. g) Uncooperative patients with significant cognitive dysfunction or psychiatric illness. h) Patients receiving any type of intraoperative periarticular infiltration (PAI) of local anesthetic by the surgeons. i) Failed spinal anesthesia. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 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 05/11/2022 research ethics committee faculty of medicine ain shams university
Ethics Committee Address
Street address City Postal code Country
38,abbassia square cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of the study is to compare the time of the postoperative first request of the rescue analgesic in case of certain pain severity assessed by VAS between the two groups. 24 hours postoperatively.
Secondary Outcome the total rescue opioids consumption, onset of ambulation, safety and complications of the used nerve blocks for the first 24 hours postoperatively. 24 hours postoperatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Ain shams university 38,abbssis square cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
the principle investigator banafseg 5 new cairo cairo 11865 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine ain shams university 38,abbassia square cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed hassan saleh mohamed banafseg 5 new cairo cairo 11865 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries mohame el razzaz mohamed.h.saleh@med.asu.edu.eg 002723497108 banafseg 5 new cairo
City Postal code Country Position/Affiliation
caio 11865 Egypt assistant lecturer of anesthesia and intensive care ain shams university
Role Name Email Phone Street address
Principal Investigator ahmed mostafa drahmed.mostafa.mohamed@med.asu.edu.eg 002723083856 makram ebid
City Postal code Country Position/Affiliation
cairo 4450113 Egypt lecturer of anesthesia and intensive care ain shams university
Role Name Email Phone Street address
Scientific Enquiries shimaa ahmed Shimaaahmed_2011@yahoo.com 002723490108 nasr city
City Postal code Country Position/Affiliation
cairo 4450113 Egypt lecturer of anesthesia and intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of the individual data collected during the trial after deidentification Study Protocol following publication open
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