Bupivacaine plus lidocaine versus bupivacaine alone 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
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ataturk University Academic / other |
| Locations | 1 site (Erzurum) |
| Trial ID | NCT07550348 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Erzurum
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.