Effectiveness of Low Volume Versus High Volume of Local Anesthetic in Ultrasound Guided Combined Supraclavicular and Interscalene Block for Upper Limb Surgery; A Randomized Controlled Double Blinded Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Analgesia
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of low versus high volumes of local anesthetic in ultrasound-guided combined supraclavicular block (SCB) and interscalene block (ISB) for upper limb surgery. This randomized, controlled trial will assess the analgesic effectiveness of low-volume local anesthetic in these blocks.
We hypothesize that a low volume will provide similar analgesic effects to a high volume, with fewer complications. The study will involve 40 adult ASA I and ASA II patients undergoing upper limb surgery, divided into two groups: Group A (low volume) and Group B (high volume).
The primary outcome will compare intraoperative and postoperative analgesic effects of different volumes.
The secondary outcome will evaluate complications related to local anesthetics (toxicity) and injection techniques (e.g., phrenic nerve palsy, pneumothorax, hematoma).
详细描述
I. Study setting and location:
The study will be conducted in Souad Kafafi Universty Hospital - Misr University for Science and Technology ( MUST).
II. Study population:
Study will be conducted on (40) adult ASA І & ASA ІІ patients who will undergo Upper limb surgery in Souad Kafafi Universty Hospital - MUST University. Patients will be divided into two equal groups; Group A; Low volume of local anesthetic and Group B; High volume of local anesthetic in Ultrasound guided combined supraclavicular and interscalene block.
III. Eligibility Criteria:
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
randomized controlled double blinded study
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
- 是
入选标准
- •Patients aged 18 to 65 of both sexes
- •ASA classification I or II
- •Scheduled for upper limp surgery
- •Will be randomized 1:1 into two groups; group A; low volume local anesthetics (15-20ml) and group B; high volume local anesthetics (30-40 ml).
排除标准
- •Patients who refuse participation.
- •Have allergies to local anesthetics.
- •Phrenic nerve dysfunction.
- •Chronic opioid use.
- •ASA III or higher classification.
- •Coagulopathy (bleeding disorders with INR > 1.5 and/or platelets < 50 000)
- •Severe chronic obstructive pulmonary disease.
- •Local infection at the injection site
研究组 & 干预措施
Group A (n=20); Low volume Local anesthetic (15-20 ml)
20 patients, will receive ultrasound guided combined Supraclavicular Block (SCB) with 7-10 ml (3.5-5 ml bupivacaine 0.5% plus 3.5-5 ml lidocaine 2%) and Interscalene Block (ISB) with 7-10 ml (3.5-5 ml bupivacaine 0.5% plus 3.5-5 ml lidocaine 2%).
干预措施: Group A; Low volume local anesthetic in Ultrasound guided combined Supraclavicular and Interscalene block for Upper limb surgery (Procedure)
Group B: ( n=20); High volume local anesthetic ( 30-40ml)
20 patients, will receive ultrasound guided combined Supraclavicular Block (SCB) with 15-20 ml (7.5-10 ml bupivacaine 0.5% plus 7.5-10ml lidocaine 2%) and Interscalene Block (ISB) with 15-20 ml (7.5-10 ml bupivacaine 0.5% plus 7.5-10 ml lidocaine 2%).
干预措施: Group B; High volume local anesthetics (30-40ml) ultrasound guided combined Supraclavicular Block (SCB) and Interscalene Block (ISB) (Procedure)
结局指标
主要结局
Analgesia
时间窗: From time of injection to end of first 24 hours
The primary outcome of this study will be to compare the analgesic and anesthetic effect of different volumes of local anesthetic in Ultrasound guided combined SCB with ISB for upper limb surgery. measured by Visual analogue scale score score (VAS) (0-10; with 0 means no pain and 10 means most severe pain).
次要结局
- complications of local anesthetic(From time of injection to end of surgery)
- complications of technique of injection(From time of injection to end of 24 hours postoperative)
- Heart Rate (HR) beat/minute(before induction of anesthesia and every 15 minutes till end of surgery)
- Mean Arterial Blood Pressure ( MAP)( mmHg)(Before anesthesia, after induction of analgesia and every 15 minutes during surgery)
研究者
Emad Lotfy Mohammed Ahmed
Lecturer of anesthesia & pain management
Misr University for Science and Technology