Bupivacaine-Lidocaine Combination Versus Bupivacaine Alone for Ultrasound-Guided Popliteal Sciatic Nerve Block in Elective Lower Extremity Surgery: A Prospective Randomized Double-Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sensory and Motor Block Onset Time
研究概览
简要总结
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.
详细描述
Background and Rationale
Peripheral nerve blocks have become an increasingly preferred technique for both anesthesia and analgesia in distal lower extremity surgery, offering advantages such as reduced opioid consumption, stable intraoperative hemodynamics, lower rates of postoperative nausea and vomiting, and enhanced early mobilization. The popliteal approach to the sciatic nerve provides effective surgical anesthesia for foot, ankle, and distal leg procedures, with high patient satisfaction and a low complication profile. Ultrasound guidance further improves block success rates by enabling direct visualization of perineural anatomical structures.
The choice of local anesthetic plays a critical role in determining block onset time, duration of sensory and motor blockade, and overall analgesic duration. Lidocaine offers rapid onset and short-to-intermediate duration, while bupivacaine provides prolonged sensory and motor blockade, thereby reducing postoperative opioid requirements. The combination of these two agents theoretically enables simultaneous achievement of rapid onset and prolonged analgesia; however, the net effect of this combination on block characteristics remains inconclusive in the current literature.
Study Design
This is a prospective, randomized, double-blind, single-center, two-arm parallel-group clinical trial conducted at Ataturk University Research Hospital, Department of Anesthesiology and Reanimation, Erzurum, Turkey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group BL (Bupivacaine-Lidocaine)
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).
干预措施: Bupivacaine-Lidocaine Combination (Drug)
Group B (Bupivacaine Alone)
Ultrasound-guided popliteal sciatic nerve block with 20 mL 0.5% bupivacaine administered in two 10 mL syringes (total volume: 20 mL).
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Sensory and Motor Block Onset Time
时间窗: From completion of injection up to 60 minutes
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.
次要结局
- Postoperative Pain Score(At 2, 4, 8, 12, and 24 hours postoperatively)
- At 2, 4, 8, 12, and 24 hours postoperatively(At 24 hours postoperatively)
- Incidence of Rebound Pain(Within 24 hours after sensory block resolution, up to 72 hours postoperatively)
- 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)
- Neurological Assessment at Postoperative Day 7(Postoperative day 7)
研究者
Ahmet Murat Yayik
Associate Professor
Ataturk University