NCT07550348 Bupivacaine-Lidocaine vs Bupivacaine for Ultrasound-Guided Popliteal Sciatic Nerve Block
| NCT ID | NCT07550348 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ataturk University |
| Condition | Lower Extremity |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-12-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
AHMET MURAT YAYIK, MD, PhD
PRINCIPAL INVESTIGATOR
Ataturk University Faculty of Medicine, Department of Anesthesiology and Reanimation
Frequently Asked Questions
Who can join the NCT07550348 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Lower Extremity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07550348 currently recruiting?
Yes, NCT07550348 is actively recruiting participants. Contact the research team at ahmetmuratyayik@gmail.com for enrollment information.
Where is the NCT07550348 trial being conducted?
This trial is being conducted at Erzurum, Turkey (Türkiye).
Who is sponsoring the NCT07550348 clinical trial?
NCT07550348 is sponsored by Ataturk University. The principal investigator is AHMET MURAT YAYIK, MD, PhD at Ataturk University Faculty of Medicine, Department of Anesthesiology and Reanimation. The trial plans to enroll 60 participants.