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

NCT07550348 | Recruiting

• 1 other identifier: B.30.2.ATA.0.01.00/927
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Lower Extremity; Nerve Block; Pain, Nerve; Pain, Postoperative

Keywords

Popliteal sciatic nerve block; Bupivacaine; Lidocaine; Local anesthetic; Ultrasound-guided nerve block; Regional anesthesia; Postoperative analgesia; Block onset time; Lower extremity surgery; QoR-15

Outcome Measures

Primary Outcomes (1)

• Sensory and Motor Block Onset Time

  Time elapsed from completion of local anesthetic injection to first achievement of block success criteria, defined as a total sensorimotor score ≥12/14 and sensory score ≥7/8. Blocks not meeting success criteria within 60 minutes will be considered failed.

  From completion of injection up to 60 minutes

Secondary Outcomes (8)

• Block Success Rate

  Within 60 minutes after injection

• Duration of Sensory Block

  Up to 72 hours after block application

• Duration of Motor Block

  Up to 72 hours after block application

• Postoperative Opioid Consumption

  First 24 hours postoperatively

• Postoperative Pain Score

  At 2, 4, 8, 12, and 24 hours postoperatively

Study Arms (2)

Group BL (Bupivacaine-Lidocaine)

EXPERIMENTAL

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).

Drug: Bupivacaine-Lidocaine Combination

Group B (Bupivacaine Alone)

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Interventions

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).

Also known as: Bupivacaine 0.5%

Group B (Bupivacaine Alone)

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).

Also known as: Lidocaine 2% + Bupivacaine 0.5%

Group BL (Bupivacaine-Lidocaine)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Wieder B, Arbisfeld J. Overriding Safety Controls. Am J Nurs. 2023 Nov 1;123(11):9. doi: 10.1097/01.NAJ.0000995280.93037.b9. No abstract available.

  PMID: 37882382 BACKGROUND

• Gallipoli A, MacLean G, Walia JS, Sehgal A. Congenital Chylothorax and Hydrops Fetalis: A Novel Neonatal Presentation of RASA1 Mutation. Pediatrics. 2021 Mar;147(3):e2020011601. doi: 10.1542/peds.2020-011601.

  PMID: 33608416 BACKGROUND

• Occhipinti G, Ruberti AA, Alcocer J, Gimenez-Mila M, Vidal B, Regueiro A. Sex differences in patients undergoing aortic valve replacement: a tale of 2 hearts. Rev Esp Cardiol (Engl Ed). 2025 Oct;78(10):916-918. doi: 10.1016/j.rec.2025.01.014. Epub 2025 Feb 6. No abstract available. English, Spanish.

  PMID: 39922556 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Neuralgia

Interventions

Lidocaine; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• AHMET MURAT YAYIK, MD, PhD

  Ataturk University Faculty of Medicine, Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

• ASLIHAN BOROGLU, MD

  Ataturk University Faculty of Medicine, Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AHMET MURAT YAYIK, MD, PhD

CONTACT

+95544259287; ahmetmuratyayik@gmail.com

ASLIHAN BOROGLU, MD

CONTACT

+905354378706; aslbrgl_92@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study solutions are prepared by a dedicated investigator not involved in block performance or outcome assessment. The patient, the anesthesiologist performing the block, and the outcome assessor are all blinded to group allocation. Randomization is based on a computer-generated random number list.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients undergoing elective distal lower extremity surgery will be randomized in a 1:1 ratio into two parallel groups. Group BL will receive ultrasound-guided popliteal sciatic nerve block with bupivacaine-lidocaine combination; Group B will receive bupivacaine alone.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 24, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)