RecruitingNot ApplicableNCT07550348

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

Bupivacaine-Lidocaine Combination Versus Bupivacaine Alone for Ultrasound-Guided Popliteal Sciatic Nerve Block in Elective Lower Extremity Surgery: A Prospective Randomized Double-Blind Trial


Sponsor

Ataturk University

Enrollment

40 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

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 20. 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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBupivacaine-Lidocaine Combination

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).

DRUGBupivacaine

Ultrasound-guided popliteal sciatic nerve block with 20 mL 0.5% bupivacaine administered in two separate 10 mL syringes (total volume: 20 mL).


Locations(1)

Ataturk University

Erzurum, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07550348


Related Trials