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RECRUITING Not applicable ClinicalTrials.gov

Bupivacaine-Lidocaine vs Bupivacaine for Ultrasound-Guided Popliteal Sciatic Nerve Block

Sponsor: Ataturk University • ClinicalTrials.gov ID: NCT07550348

Registry updated: 2026-10-19
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Description

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.

Interventions

  • Bupivacaine-Lidocaine Combination (Drug)
    Ultrasound-guided popliteal sciatic nerve block with 10 mL 2% lidocaine and 10 mL 0.5% bupivacaine administered sequentially in separate syringes (total volume: 20 mL).
  • Bupivacaine (Drug)
    Ultrasound-guided popliteal sciatic nerve block with 20 mL 0.5% bupivacaine administered in two separate 10 mL syringes (total volume: 20 mL).

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

Conditions

Lower Extremity Nerve Block Pain, Postoperative Pain, Nerve

Locations

  • Ataturk University — Erzurum, Turkey (Türkiye)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record