Overriding Safety Controls.
Bracha Wieder, Jaime Arbisfeld
https://pubmed.ncbi.nlm.nih.gov/37882382Actively Recruiting
Led by Ataturk University · Updated on 2026-05-12
60
Participants Needed
1
Research Sites
12 weeks
Total Duration
Researchers are comparing two local anesthetic methods for ultrasound-guided popliteal sciatic nerve block in adults aged 18 to 65 undergoing elective distal lower leg surgery. This study focuses on how quickly sensory and motor blockades begin and evaluates several postoperative outcomes such as pain levels, opioid use, and recovery quality. The trial is conducted at Ataturk University Research Hospital in Turkey with 60 participants divided into two groups. Participants will receive one of two treatments before surgery: one group gets a combination of lidocaine and bupivacaine, while the other group receives bupivacaine alone. Both treatments involve 20 mL total volume administered via ultrasound guidance to the popliteal sciatic nerve. Some patients may also receive an additional adductor canal block. During surgery, sedation and vital signs are carefully monitored, and standardized postoperative pain relief is provided. Throughout the study, researchers will assess block onset time, success rates, duration of sensory and motor block, and pain scores at multiple time points up to 24 hours after surgery. They will also monitor opioid use, quality of recovery, and any rebound pain. Neurological assessments are performed one week after surgery to check for any nerve issues. The study uses a double-blind design, with patients and outcome assessors unaware of the treatment group.
CONDITIONS
Bupivacaine-Lidocaine vs Bupivacaine for Ultrasound-Guided Popliteal Sciatic Nerve Block
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive an ultrasound-guided popliteal sciatic nerve block with either a bupivacaine-lidocaine combination or bupivacaine alone before elective lower extremity surgery.
1 visit (in-person) for block administration and surgery
Duration - Up to 7 days postoperatively
Participants are monitored for pain levels, opioid consumption, block duration, and neurological status following the nerve block and surgery.
Multiple visits including assessments at 2, 4, 8, 12, and 24 hours postoperatively and a neurological assessment at postoperative day 7
Total: 1 location
1
Ataturk University
Erzurum, Turkey (Türkiye)
Actively Recruiting
A
AHMET MURAT YAYIK, MD, PhD
A
ASLIHAN BOROGLU, MD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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