Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Bupivacaine plus lidocaine versus bupivacaine alone for ultrasound-guided popliteal sciatic nerve block

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

Run by Ataturk University · NCT07550348 · Data updated 2026-11-12

This trial will test whether adding lidocaine to bupivacaine gives faster numbness and longer-lasting pain relief for adults having below-knee (foot or ankle) surgery with an ultrasound-guided popliteal sciatic nerve block.

More Pain, Postoperative trials

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment60 (estimated)
SponsorAtaturk University
Academic / other
Locations1 site (Erzurum)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedDecember 1, 2026
Study endsMarch 1, 2027
Registry record updatedOctober 19, 2026
Trial IDNCT07550348 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–65 years old with ASA physical status I–III, BMI 18–35 kg/m², scheduled for elective below-knee lower extremity surgery, who can give informed consent and have no contraindications to local anesthetics are ideal candidates.

Probably not a fit

Patients with known allergy to local anesthetics, severe cardiac/hepatic/renal disease, pre-existing peripheral neuropathy, pregnancy, BMI ≥35, active anticoagulant therapy, prior popliteal surgery/scar, or chronic home opioid use are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, double-blind, single-center trial at Ataturk University comparing two local anesthetic regimens for ultrasound-guided popliteal sciatic nerve block in adults undergoing elective distal lower extremity surgery. Sixty patients aged 18–65 (ASA I–III, BMI 18–35) will be randomized 1:1 to receive either 10 mL 2% lidocaine plus 10 mL 0.5% bupivacaine or 20 mL 0.5% bupivacaine alone prior to surgery. The primary outcome is onset time of sensory and motor blockade; secondary outcomes include block success rate, duration of sensory and motor block, postoperative opioid consumption, Numeric Rating Scale pain scores at 2, 4, 8, 12, and 24 hours, QoR-15 score, and incidence of rebound pain. Ultrasound guidance and standardized block technique will be used to ensure consistent administration across participants.

Why it matters

Potential benefit: If successful, the combination could provide quicker onset and prolonged postoperative analgesia, lowering opioid needs and improving early recovery.

How similar studies have gone: Prior studies suggest combining a short-acting agent like lidocaine with a long-acting agent like bupivacaine can speed onset while maintaining duration, but published results are mixed and not definitive.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Ataturk University
    Erzurum, Turkey (Türkiye)
    Recruiting

Study contacts

  • Principal investigator: AHMET MURAT YAYIK, MD, PhD — Ataturk University Faculty of Medicine, Department of Anesthesiology and Reanimation
  • Study coordinator: AHMET MURAT YAYIK, MD, PhD
  • Email: ahmetmuratyayik@gmail.com
  • Phone: +95544259287

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.