A Triple-Blind Randomized Controlled Trial of Erector Spinae Plane Block With Bupivacaine Versus Placebo in Patients Undergoing Medical Thoracoscopy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) for Pain
研究概览
简要总结
PlAcebo versus erector spINae pLane block for mEdical ThoracoScopy Study (PAINLESS). This is a prospective triple-blind, randomized controlled trial that evaluates the efficacy of erector spinae plane block (ESPB) with Bupivacaine in reducing pain after medical thoracoscopy (MT) in addition to monitored anesthesia care vs monitored anesthesia care alone.
详细描述
This is a single-site prospect triple-blind, randomized controlled trial, that evaluates the efficacy of erector spinae plane (ESP) block with Bupivacaine in reducing pain after medical thoracoscopy (MT). The study aims to compare the effectiveness of ESP block with monitored anesthesia care (MAC) vs MAC alone for patients undergoing MT. Patient will be evaluated post operatively in the post anesthesia care unit and 24 hours after the procedure.
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
Triple blind study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ESP with Bupivacaine Group
Erector spinae plane block with bupivacaine.
干预措施: Bupivacaine injection (Drug)
ESP with Bupivacaine Group
Erector spinae plane block with bupivacaine.
干预措施: Monitored Anesthesia Care (Other)
ESP with Placebo
Erector spinae plane injection with a placebo (normal saline).
干预措施: Placebo (Drug)
ESP with Placebo
Erector spinae plane injection with a placebo (normal saline).
干预措施: Monitored Anesthesia Care (Other)
结局指标
主要结局
Visual Analog Scale (VAS) for Pain
时间窗: 2 hours after the intervention
Global chest pain score measured using the Visual Analog Scale (VAS) post-procedure in recovery. Participants will be asked to mark the level of their pain along a line, score ranges 0 (no-pain) to 100 (worst-imaginable pain), with higher scores indicating worse outcomes.
次要结局
- Type of Analgesic use(within the first 24 hours after the intervention)
- Change in the Numerical Rating Scale(At 2 hours post-intervention and 24 hours post-intervention)
- Number of Analgesic use(within the first 24 hours after the intervention)
- Quality of Recovery-15 (QoR-15) Survey Score(within the first 24 hours after the intervention)
- Dosage of Analgesic use(within the first 24 hours after the intervention)
研究者
Udit Chaddha
Associate Professor
Icahn School of Medicine at Mount Sinai