Sub Sartorial Canal Block and Popliteal Block Versus Femoral Block and Popliteal Block in Ankle Surgeries
NCT06744010 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2024-12-20
Summary
Ankle surgeries are severely painful. A sciatic nerve block is typically not enough to cover the pain sources (Delbos et al., 2019).
It can be speculated that approaching the saphenous nerve in the subsartorial compartment distal to the point where it pierces the vastoadductor membrane but proximal to the point where it penetrates the crural fascia and becomes subcutaneous would selectively target the saphenous nerve without any decrease of quadriceps strength (Jensen et al., 2024).
Previous study showed that femoral nerve block (FNB) provides good surgical anesthesia and good postoperative pain control for patients with ankle conditions (Lee et al., 2014). However, FNB leads to femoral quadriceps muscle weakness (Jaeger et al., 2013).
Consequently, quadriceps weakness results in functional impairment and it is associated with an increased risk of postoperative falls (Johnson et al., 2013).
Thus far, attempts to reduce quadriceps involvement after FNB without compromising analgesia have not been successful (Li et al., 2019).
Partially because of the increase in the use of ultrasound guidance, a more targeted approach that only blocks sensory fibers of the femoral nerve that supply the operative site has been attempted; thus, the feasibility of sub sartorial canal block has been studied (Kopp et al., 2017).
In recent years, sub sartorial canal block has been successfully used for postoperative pain control after knee surgery (Lavand'homme et al., 2022).
However, no randomized, control study has compared sub sartorial canal block to femoral nerve block for ankle surgeries. We hypothesized that compared to femoral nerve block, sub sartorial canal block would demonstrate noninferior pain scores during surgery and until 48 hours postoperatively and cause less weakness in the quadriceps.
Conditions
- Sub Sartorial Canal Block and Popliteal Block Versus Femoral Block and Popliteal Block in Ankle Surgeries
Interventions
- PROCEDURE
-
Sub sartorial canal block and popliteal block in ankle surgeries
All patients will be anesthetized with PNBs for surgery. * PNBs will be performed in a block room at least 30minute preoperatively. * All PNBs will be performed under ultrasound guidance (LOGIQ P6, GE Healthcare; Chicago, IL) using a high-frequency linear transducer (3.4-10.8MHz). * All blocks will be performed after skin preparation with 2% chlorhexidine gluconate by 1 orthopedic surgeon (YUP) with vast experience in ultrasound-guided nerve block techniques. * A 22-ga Tuohy needle will be introduced in-plane and 2 to 3mL of saline will be used to confirm the correct position of the needle tip near the target nerve. * The study medication will be administered through the needle as a bolus of 20mL of a 1:1 mixed solution of bupivacaine 0.75% and lidocaine 1%. * The total volume per every block will be 20 ml in the form of bupivacaine 1.25% with 1:200,000 epinephrine and 250 mg Mgso4.
- PROCEDURE
-
femoral block and popliteal block in ankle surgeries
* All patients will be anesthetized with PNBs for surgery. * PNBs will be performed in a block room at least 30minute preoperatively. * All PNBs will be performed under ultrasound guidance (LOGIQ P6, GE Healthcare; Chicago, IL) using a high-frequency linear transducer (3.4-10.8MHz). * All blocks will be performed after skin preparation with 2% chlorhexidine gluconate by 1 orthopedic surgeon (YUP) with vast experience in ultrasound-guided nerve block techniques. * A 22-ga Tuohy needle will be introduced in-plane and 2 to 3mL of saline will be used to confirm the correct position of the needle tip near the target nerve. * The study medication will be administered through the needle as a bolus of 20mL of a 1:1 mixed solution of bupivacaine 0.75% and lidocaine 1%. * The total volume per every block will be 20 ml in the form of bupivacaine 1.25% with 1:200,000 epinephrine and 250 mg Mgso4.
Sponsors & Collaborators
-
Fayoum University Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-06-05
- Primary Completion
- 2024-09-05
- Completion
- 2024-11-05
Countries
- Egypt
Study Locations
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