Investigation Into the Effect of 0.25% Bupivacaine for Interscalene Peripheral Nerve Block vs 0.125% Bupivacaine on Pulmonary Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Abnormal Lung Function
研究概览
简要总结
Peripheral nerve blocks are used to provide post-operative pain relief. Nerve blocks in the neck, in the interscalene area, provide pain relief after shoulder surgery but can cause temporary weakness or paralysis of the diaphragm. The investigators hypothesized that a lower concentration of bupivacaine would cause less weakness of the diaphragm but still provide good pain relief. Lung function and pain control was studied after interscalene peripheral nerve block with 20 milliliters of 0.25% bupivacaine or 0.125% bupivacaine.
详细描述
Prior to placement of interscalene brachial plexus peripheral nerve block (ISPNB), diaphragm function was assessed using ultrasound as normal, no movement, or paradoxical. Room air pulse oximetry (SpO2) was recorded. Patients were randomized to receive either 0.25% bupivacaine or 0.125% bupivacaine. ISPNB was performed using a coded syringe of the study drug, so that the anesthesiologists performing the nerve block, the patient, and the nurses assessing the patient were blinded as to the concentration. Patients were given a general endotracheal anesthesia for rotator cuff repair, and opioids were administered at the discretion of the attending anesthesiologist. When patients met criteria for PACU discharge, diaphragm function was again assessed using ultrasound and room air SpO2 was recorded.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients presenting for outpatient rotator cuff repair
- •English as the primary language
排除标准
- •evidence of peripheral nerve damage on affected side
- •refusal of peripheral nerve block
- •pregnant women
- •lung disease, including obstructive sleep apnea
- •chronic opioid use
- •mental handicap
研究组 & 干预措施
0.25% bupivacaine
interscalene nerve block with 0.25% bupivacaine
干预措施: interscalene block with 0.125% bupivacaine (Drug)
0.125% bupivacaine
interscalene nerve block with 0.125% bupivacaine
干预措施: interscalene nerve block with 0.25% bupivacaine (Drug)
结局指标
主要结局
Abnormal Lung Function
时间窗: At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery
Lung function was evaluated by examining diaphragm movement using ultrasound imaging and change in room air oxygen saturation (SpO2). Diaphragm movement was assessed using ultrasound as Normal (diaphragm moves caudad with inspiration), Abnormal (diaphragm does not move caudad with inspiration), and Paradoxical (diaphragm moves cephalad with inspiration). Both diaphragm function and room air SpO2 were assessed prior to any intervention to establish a baseline, and again on discharge from the PACU, within 5 hours of the completion of surgery.
次要结局
- Satisfaction With Pain Control(Within 30 days)
- Pain Relief(At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery)
研究者
Elizabeth Thackeray
Assistant Professor of Anesthesiology
University of Utah