- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07418307
Comparison Between Combined Biceps Femoris Short Head Block and Adductor Canal Block Versus Genicular Nerve Block
Enhanced Analgesia in Elderly After Total Knee Arthroplasty Using Combined Biceps Femoris Short Head Block and Adductor Canal Block Versus Genicular Nerve Block
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marwa M Medhat, M.D
- Phone Number: 01002828937
- Email: medhatmarwa9@gmail.com
Study Contact Backup
- Name: Howida A Kamal, M.D
- Phone Number: 01225096755
- Email: K.Howida@yahoo.com
Study Locations
-
-
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Zagazig, Egypt
- Faculty of Medicine,Zagazig University
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Contact:
- Marwa M Medhat, M.D
- Phone Number: 01002828937
- Email: medhatmarwa9@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patient acceptance
- Physical status: ASA I, II and Ⅲ.
- Body mass index (BMI): 18.5 - 35 kg/m2.
- Type of operations: total knee arthroplasty.
Exclusion Criteria:
- Known hypersensitivity to dexamethasone or bupivacaine.
- Coagulation disorders or taking drugs affect surgical hemostasis.
- Patients with pre-existing neurological deficits.
- Uncooperative patient or with altered mental status.
- Patient with advanced cardiovascular or respiratory diseases or uncontrolled diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group (C)
The patient will receive combined biceps femoris short head block and adductor canal block
|
Adductor Canal Block high-frequency probe will be placed transversely on the anterior thigh midpoint between inguinal crease and medial condyle (depth 3-5 cm). The needle will be advanced in-plane from lateral to medial through sartorius or vastus medialis muscle toward the femoral artery. Then (10 ml of 0.25% bupivacaine and 2 mg dexamethasone) will be injected after negative aspiration, with confirming spread around the artery without vascular puncture. Biceps femoris short head block The probe will be placed on the distal posterior thigh to visualize biceps femoris muscle near the lateral supracondylar line of the femur. The needle will be inserted to the interface between biceps femoris and femur cortex. Then (25 ml of 0.25% bupivacaine and 2 mg dexamethasone), with observing muscle lift and circumferential spread along the bone surface . |
|
Active Comparator: Group(G)
The patient will receive genicular nerve block
|
Position the patient will be placed in supine position with the knee slightly flexed via a pillow in the popliteal fossa. Use a high-frequency linear ultrasound transducer. Superolateral genicular nerve (SLGN): the transducer will be placed coronally over lateral femoral epicondyle, with sliding proximally to femur metaphysis; identifying artery between vastus lateralis fascia and bone. Superomedial genicular nerve (SMGN): the transducer will be placed coronally over medial femoral epicondyle, proximal to adductor tubercle at femur metaphysis; artery between vastus medialis fascia and bone. Inferomedial genicular nerve (IMGN): the transducer will be placed coronally over medial tibial condyle, distal to metaphysis; artery beneath medial collateral ligament. • Inferolateral genicular nerve (ILGN, optional): the transducer will be placed coronally over lateral tibial epicondyle to fibula head; artery between collateral ligament and tibia |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time of first rescue analgesia (naluphine)
Time Frame: 24 hours postoperative
|
to the duration from the block to the moment when the patient first requires or requests supplemental nalbuphine due to breakthrough pain
|
24 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patient's satisfaction
Time Frame: 24 hours postoperative
|
The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia)
|
24 hours postoperative
|
|
block performance time
Time Frame: time of performance of the block
|
time refers to the duration required to prepare, image (e.g., via ultrasound), insert the needle, and inject local anesthetic to complete a regional nerve block procedure.
|
time of performance of the block
|
|
Pain intensity
Time Frame: 30 minutesn2, 4, 8, 12, 18 , and 24 hours postoperative
|
10-point NRS [(0 = no pain, 10 = worst imaginable pain), 1-3: Mild pain (nagging, annoying, slightly interfering with activities of daily living (ADLs), 4 - 6: Moderate pain (significantly interfering with ADLs, 7 - 10: Severe pain (disabling, unable to perform ADLs)
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30 minutesn2, 4, 8, 12, 18 , and 24 hours postoperative
|
|
Total amount of rescue analgesia (nalbuphine)
Time Frame: first 24 hours postoperative
|
the cumulative dose of nalbuphine administered as supplemental pain relief during a defined postoperative observation period, typically when pain scores exceed a predefined threshold like NRS ≥4
|
first 24 hours postoperative
|
|
assess functional recovery
Time Frame: at 12 hours and 24 hours postoperative
|
(knee range of motion active flexion /extension,
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at 12 hours and 24 hours postoperative
|
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Block related complications
Time Frame: 24 hours postoperative
|
(motor weakness, hematoma, local anesthetic toxicity,..)
|
24 hours postoperative
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Howida A Kamal, M.D, faculty of medicine,zagazig university Egypt
Publications and helpful links
General Publications
- You D, Qin L, Li K, Li D, Zhao G, Li L.,et al. A meta-analysis on advantages of peripheral nerve block post-total knee arthroplasty. Korean J Pain 2021; 34:271-287.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ZU-IRB#2002/28-Jan-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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