Erector Spinae Plane Block vs. Pecto-intercostal Fascial Plane Block vs. Control for Sternotomy: A Prospective Randomized Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Opioid Consumption during first 48 hours post-op
研究概览
简要总结
This is a randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of two types of peripheral nerve blocks, specifically erector spinal plane (ESP) block and pecto-intercostal fascial (PIF) plane block.
90 subjects, from 18-85 years of age, undergoing cardiac surgery with median sternal incision will be enrolled at Mount Sinai Morningside Hospital Center. Study participation will last from the time of pre-operative evaluation to 72 hours after surgery. Subjects will be randomly assigned to receive 1 of the 3 different regimens at the beginning of surgery. Opioid consumption and pain scores after surgery will be evaluated. Though unlikely, risks include systemic absorption of local anesthetic, which can result in both central nervous system and cardiac toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The anesthesiologist assessing the patient will be blinded
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-85 years old
- •Scheduled to undergo cardiac procedures involving sternotomy
- •All genders
排除标准
- •ASA class V
- •Urgent or emergent surgery
- •Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
- •History of substance abuse or chronic opioid use
- •Patient refusal or inability to consent
研究组 & 干预措施
ESP group
Patient will receive ESP block with ultrasound guidance the transverse process of the vertebra at T7 is visualized and 20 mL of 0.25% bupivacaine will be injected between the transverse process and the erector spinae muscle on each side using a 21-gauge block needle.
干预措施: Ultrasound (Procedure)
PIF group
Patient will receive PIF block after intubation with ultrasound placed 1-2 cm lateral to the sternal border and the pectoralis major and external intercostal muscles are visualized at the level of ribs 3-4 where 10 mL of 0.25% bupivacaine will be injected on each side using a 21-gauge block needle.
干预措施: PIF block (Procedure)
ESP group
Patient will receive ESP block with ultrasound guidance the transverse process of the vertebra at T7 is visualized and 20 mL of 0.25% bupivacaine will be injected between the transverse process and the erector spinae muscle on each side using a 21-gauge block needle.
干预措施: ESP block (Procedure)
PIF group
Patient will receive PIF block after intubation with ultrasound placed 1-2 cm lateral to the sternal border and the pectoralis major and external intercostal muscles are visualized at the level of ribs 3-4 where 10 mL of 0.25% bupivacaine will be injected on each side using a 21-gauge block needle.
干预措施: Ultrasound (Procedure)
ESP group
Patient will receive ESP block with ultrasound guidance the transverse process of the vertebra at T7 is visualized and 20 mL of 0.25% bupivacaine will be injected between the transverse process and the erector spinae muscle on each side using a 21-gauge block needle.
干预措施: Bupivacain (Drug)
PIF group
Patient will receive PIF block after intubation with ultrasound placed 1-2 cm lateral to the sternal border and the pectoralis major and external intercostal muscles are visualized at the level of ribs 3-4 where 10 mL of 0.25% bupivacaine will be injected on each side using a 21-gauge block needle.
干预措施: Bupivacain (Drug)
结局指标
主要结局
Opioid Consumption during first 48 hours post-op
时间窗: Post-operative 48 hours
The amount of opioid consumption (in mg IV morphine equivalents) during the first 48 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
Opioid Consumption during first 24 hours post-op
时间窗: Post-operative 24 hours
The amount of opioid consumption (in mg IV morphine equivalents) during the first 24 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
Opioid Consumption during first 72 hours post-op
时间窗: Post-operative 72 hours
The amount of opioid consumption (in mg IV morphine equivalents) during the first 72 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
次要结局
- Visual Analogue Score (VAS) Pain Score post-op 48 hours(Post-operative 48 hours)
- Visual Analogue Score (VAS) Pain Score post-op 72 hours(Post-operative 72 hours)
- Visual Analogue Score (VAS) Pain Score post-op 24 hours(Post-operative 24 hours)
研究者
Ali Nima Shariat
Assistant Professor
Icahn School of Medicine at Mount Sinai