CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 72 enrolled
Drug / intervention
Sub sartorial canal block and popliteal block in ankle surgeries +1 moreprocedure
Likely dose
Not stated in record
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Search/NCT06744010
NCT06744010Phase 4Completed

Sub Sartorial Canal Block and Popliteal Block Versus Femoral Block and Popliteal Block in Ankle Surgeries

Fayoum University Hospital·interventional·Posted Dec 20, 2024·Updated Dec 20, 2024

In Brief

A Phase 4 clinical trial evaluating Sub sartorial canal block and popliteal block in ankle surgeries and femoral block and popliteal block in ankle surgeries for Sub Sartorial Canal Block and Popliteal Block Versus Femoral Block and Popliteal Block in Ankle Surgeries. Completed, enrolled 72 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

Phase 4CompletedFinished
20252026
First PostedDec 20, 2024
Enrollment StartJun 5, 2024
Primary CompletionSep 5, 2024
Study CompletionNov 5, 2024
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 1.5 years ago

Interventions

Sub sartorial canal block and popliteal block in ankle surgeriesprocedure

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.

femoral block and popliteal block in ankle surgeriesprocedure

* 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.