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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Ataturk University
RECRUITING
Erzurum
Contact Information
Primary
AHMET MURAT YAYIK, MD, PhD
ahmetmuratyayik@gmail.com
+95544259287
Backup
ASLIHAN BOROGLU, MD
aslbrgl_92@outlook.com
+905354378706
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 60
Treatments
Experimental: Group BL (Bupivacaine-Lidocaine)
Ultrasound-guided popliteal sciatic nerve block with 10 mL 2% lidocaine + 10 mL 0.5% bupivacaine administered sequentially in separate syringes (total volume: 20 mL).
Active_comparator: Group B (Bupivacaine Alone)
Ultrasound-guided popliteal sciatic nerve block with 20 mL 0.5% bupivacaine administered in two 10 mL syringes (total volume: 20 mL).
Related Therapeutic Areas
Sponsors
Leads: Ataturk University

This content was sourced from clinicaltrials.gov

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