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.: PACTR202304721545851 Date of Approval: 18/04/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Analgesic Efficacy of Blocking Nerve to Vastus Lateralis Muscle versus Lateral Femoral Cutaneous Nerve after Knee Surgeries
Official scientific title Analgesic Efficacy of Blocking Nerve to Vastus Lateralis Muscle versus Lateral Femoral Cutaneous Nerve after Knee Surgeries
Brief summary describing the background and objectives of the trial Total knee arthroplasty (TKA) surgery is indicated for patients with painful degenerative diseases affecting the knee joint. Spinal anesthesia is preferred for anesthesia in patients undergoing surgeries of lower limbs unless there is any contraindication for spinal anesthesia. Regional anesthesia is the best option for life‑saving operations in emergency surgeries where both general and neuraxial anesthesia were risky or contraindicated. Recent advances have included the introduction of single shot and continuous adductor canal blocks which have been reported to provide analgesia after knee joint replacement surgery while preserving motor function in most cases. The innervation of the knee joint follows Hilton's Law which states that a joint is innervated by the articular branches of the muscles which move the joint. Vastus lateralis(VL) is the largest muscle of the quadriceps muscle complex. The nerve to vastus lateralis (NVL) is a branch of the femoral nerve and most commonly has two divisions. The proximal division of NVL enters VL muscle while the distal division continues to course distally along the anteromedial border of the VL with the descending branch of the lateral circumflex femoral artery. The most distal branches of NVL negotiate the posterior edge of VL muscle and divide into a varying number of filaments which innervate the anterolateral portion of the joint capsule, reaching as far as the lateral edge of the patella. The lateral femoral cutaneous nerve (LFCN) supplies portions of the anterior and lateral thigh, extending to the knee. Therefore, we planned this study to compare the analgesic efficacy of nerve to vastus lateralis block versus lateral femoral cutaneous nerve block for reducing pain in the lateral aspect of knee following knee surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/02/2023
Actual trial start date 18/02/2023
Anticipated date of last follow up 01/09/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
MKSU5014 Faculty of Medicine, Kafr Elsheikh University
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Spinal anesthesia and adductor canal block once once Spinal anesthesia is preferred for anesthesia in patients undergoing surgeries of lower limbs unless there is any contraindication for spinal anesthesia. When hyperbaric bupivacaine 0.5% is used alone in spinal anesthesia, it might be of relatively short duration of action with the need for switching to general anesthesia if the surgical procedure exceeds the drug’s duration of action. Adductor canal block (ACB) a relatively new peripheral nerve block introduced by Lund et al, used in patients undergoing orthopedic procedures. It affects the two largest sensory contributors from the femoral nerve to the knee; the saphenous nerve and the branch to the vastus medialis, and also the articular branches of the obturator nerve. Moreover, the block is distal to most of the efferent branches to the quadriceps muscle and therefore largely preserves its strength. 30 Active-Treatment of Control Group
Experimental Group nerve to vastus lateralis block once once The Nerve to Vastus Lateralis block will be performed with the patient supine and the knee extended the femoral artery is located and followed distally. The LCFA is commonly located between rectus femoris and VL muscles along a line between the anterior superior iliac spine and the lateral aspect of the patella corresponding to the lateral intermuscular septum. Lateral to LCFA is the distal branch of NVL which is readily visible . A regional block needle is inserted at the lateral aspect of the thigh and advanced under ultrasound guidance towards NVL around which up to 5 mL of 0.5% hyperbaric solution will be injected under visualization by linear ultrasound probe. 30
Experimental Group lateral femoral cutaneous nerve block once once The Lateral Femoral Cutaneous nerve block will be performed with the patient in the supine or lateral position. Palpation of the anterior superior spine provides the initial landmark for transducer placement; the transducer is first positioned at 2 cm inferior and medial to the ASIS and adjusted accordingly. Typically, the nerve is identified slightly more distally in its course. 5-8 mL of 0.5% hyperbaric solution will be injected under visualization by linear ultrasound probe. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patient’s approval. • Age: 40 – 75 years. • Sex: Both males and females. • Physical Status: American Society of Anesthesiologists (ASA) II & III • Patient refusal • Age: >75 and <40 years. • Allergy to local anesthetics, systemic opioids and any of the drugs included in the multimodal perioperative pain protocol. • Revision surgery. • Patients with impaired kidney functions and coagulopathy. • Chronic pain syndromes and patients with chronic opioid use defined as use of regular daily doses of systemic narcotics for the past 6 months prior to the surgery. • BMI of 40 or more. • Physical Status: American Society of Anesthesiologists (ASA) IV. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 75 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 09/01/2023 Kafr Elsheikh University Faculty of Medicine Scientific Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
el gish road kafr elsheikh 33512 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual Analogue Scale (VAS) 6,12,24,48 hours at rest and 24,48 hours after mobilization
Secondary Outcome 1. Time to first rescue analgesia. 2. Total Morphine consumption in the first 24 hours. 3. Anesthetic complications 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Kafr Elsheikh University el gish road kafr elsheikh Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
islam abousharkh street number 15 Elzohor district zagazig Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Kafr Elsheikh University el gish road kafr elsheikh Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator islam abousharkh islam.mnm@gmail.com +201000107726 street number 15 El zohor district
City Postal code Country Position/Affiliation
zagazig Egypt resident doctor
Role Name Email Phone Street address
Scientific Enquiries sherif arafa sherifarafa1020@gmail.com +201005714014 tanta
City Postal code Country Position/Affiliation
tanta Egypt assistant professor
Role Name Email Phone Street address
Public Enquiries omar elsheshtawy ohatem140@gmail.com +201096882518 benha
City Postal code Country Position/Affiliation
benha Egypt assistant lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in article after deidentification (text, tables, figures and appendices) Study Protocol beginning 9 months and ending 36 months following article publication researchers who provide a methodologically sound proposal
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