Bupivacaine-Lidocaine vs Bupivacaine for Ultrasound-Guided Popliteal Sciatic Nerve Block
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAtaturk University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacaine-Lidocaine Combination
DrugUltrasound-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).
Bupivacaine
DrugUltrasound-guided popliteal sciatic nerve block with 20 mL 0.5% bupivacaine administered in two separate 10 mL syringes (total volume: 20 mL).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Group BL (Bupivacaine-Lidocaine)Experimental treatment 1 intervention
Group B: Group B (Bupivacaine Alone)Active comparator 1 intervention
Trial outcomes
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.
Time frame
From completion of injection up to 60 minutesSecondary outcomes
1
Block Success Rate
Proportion of patients achieving a total sensorimotor score ≥12/14 with a sensory score ≥7/8 within 60 minutes of injection.
Time frame
Within 60 minutes after injection2
Duration of Sensory Block
Time from block success to first return of sensation in the blocked dermatomes, assessed by pinprick test.
Time frame
Up to 72 hours after block application3
Duration of Motor Block
Time from block success to recovery of voluntary movement in the blocked extremity, assessed by motor scoring of tibial, deep peroneal, and superficial peroneal nerve territories.
Time frame
Up to 72 hours after block application4
Postoperative Opioid Consumption
Total amount of rescue tramadol (mg) administered intravenously during the first 24 hours postoperatively for NRS pain score ≥4.
Time frame
First 24 hours postoperativelySponsors and contacts
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Source ClinicalTrials.gov