Bupivacaine-Lidocaine vs Bupivacaine for Ultrasound-Guided Popliteal Sciatic Nerve Block (NCT07550348) | Clinical Trial Compass
RecruitingNot Applicable
Bupivacaine-Lidocaine vs Bupivacaine for Ultrasound-Guided Popliteal Sciatic Nerve Block
Turkey (Türkiye)60 participantsStarted 2025-12-01
Plain-language summary
This prospective, randomized, double-blind clinical trial aims to compare the efficacy of two local anesthetic regimens for ultrasound-guided popliteal sciatic nerve block in adult patients undergoing elective distal lower extremity surgery.
Eligible participants (ages 18-65, ASA physical status I-III, BMI 18-35 kg/m²) will be randomized into two equal groups of 30. Patients in Group BL will receive a combination of 10 mL 2% lidocaine and 10 mL 0.5% bupivacaine, while patients in Group B will receive 20 mL 0.5% bupivacaine alone, administered via ultrasound-guided popliteal sciatic nerve block prior to surgery.
The primary outcome is the onset time of sensory and motor blockade. Secondary outcomes include block success rate, duration of sensory and motor block, postoperative opioid consumption, pain scores assessed by the Numeric Rating Scale (NRS) at 2, 4, 8, 12, and 24 hours postoperatively, Quality of Recovery-15 (QoR-15) score, and incidence of rebound pain.
The study is conducted at Ataturk University Research Hospital, Department of Anesthesiology and Reanimation, Erzurum, Turkey.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 18 and 65 years
* American Society of Anesthesiologists (ASA) physical status classification I, II, or III
* Scheduled for elective distal lower extremity surgery (below-knee)
* Body mass index (BMI) between 18 and 35 kg/m²
* Provision of written informed consent
Exclusion Criteria:
* Refusal to participate in the study
* Morbid obesity (BMI ≥35 kg/m²)
* Known allergy or hypersensitivity to any local anesthetic agent
* Severe cardiac, hepatic, or renal disease
* Pre-existing neurological deficits or peripheral neuropathy
* Use of anticoagulant therapy
* History of prior surgery or significant scar tissue in the popliteal fossa
* Pregnancy
* Chronic opioid use at home
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensory and Motor Block Onset Time
Timeframe: From completion of injection up to 60 minutes