Fayoum University Hospital
Al Fayyum, 63514, Egypt
NCT Number: NCT06744010
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.
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Notify Me19 year–65 year
All sexes
Interventional
Phase 4
Al Fayyum, 63514, Egypt
Sample size was calculated using Power Analysis and Sample Size Software (PASS 2020) "NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass". Based on a previously published study (Lavand'homme et al., 2022) and (Joe et al., 2016); the VAS pain scores of the adductor canal block group were not inferior during and after the operation compared to those of the FNB group. At 30 minutes and 2 hours after anesthesia, patients who received an adductor canal block had significantly higher average dynamometer readings than those who received a FNB (34.2±20.4 and 30.4±23.7 vs 1.7±3.7 and 2.3±7.4, respectively), and the results were similar at 24 and 48 hours after anesthesia. Based on this, a minimal total hypothesized sample size of 60 eligible patients will be needed taking into consideration 95% level of confidence, an effect size of 1/100 and 5% margin of error using two-sided proportional Z- test. Sample size will be increased 20% for possible dropout rate, so 72 patients will be enrolled in the study (36 in each group).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients will be anesthetized with PNBs for surgery.
Time frame: 15 minute after the block then at skin incision and "2, 6, 12, 24, and 48 hours postoperatively
Visual analogue score at 15 minute after the block then at skin incision and "2, 6, 12, 24, and 48 hours postoperatively
Time frame: In the first 48 hours after surgery.
Time frame: In the first 48 hours after surgery.
Number of patients requiring analgesic rescue in the first 48 hours after surgery.
Time frame: In the first 48 hours after surgery.
Total opioid consumption.
Time frame: In the first 48 hours
Duration of the procedure
Time frame: 20 to 30 minutes before surgery
Time to full anesthesia
Time frame: 6 hours
Operative time
Time frame: 48 hours after surgery
Recovery time
Time frame: In the first 48 hours after surgery
Patient satisfaction
Time frame: In the first 48 hours after surgery
Incidence of complications
Fayoum University Hospital
Other
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