Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07550348

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

Led by Ataturk University · Updated on 2026-05-12

60

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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/m8
  • Provision of written informed consent
Not Eligible

You will not qualify if you...

  • Refusal to participate in the study
  • Morbid obesity (BMI 235 kg/m8)
  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ataturk University

Erzurum, Turkey (Türkiye)

Actively Recruiting

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Research Team

A

AHMET MURAT YAYIK, MD, PhD

CONTACT

A

ASLIHAN BOROGLU, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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