Effects of Continuous Erector Spinae Plane Blocks on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of patients who require escalation to (ie, a new prescription for) an opioid-iv-patient controlled analgesia (iv-PCA)
研究概览
简要总结
Single-shot erector spinae plane (ESP) blocks (ESPB) are emerging as an intervention to improve pain and minimize opioid consumption after lumbar spine surgery. Although promising, there is minimal evidence to support routine use, and widespread clinical adoption may be limited to centers with advanced regional anesthesia resources and expertise. Continuous ESP catheter techniques may solve these problems but are associated with challenges of their own. This trial will investigate the role of adding surgeon-placed, continuous ESP catheters to single-shot ESPBs for patients undergoing multilevel spine surgery. It will assess whether adding ESP catheters with ropivacaine infusion for 48 hours after surgery offers opioid-minimizing analgesia and improves patient quality of recovery, compared to ESP catheters with saline/placebo infusion for 48 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-80
- •Presenting for elective multilevel (>2 spinal levels) spinal fusion
- •Lumbar, thoracic, and thoracolumbar procedures included
- •Posterior surgical approach
- •Willing and able to follow the study protocol
- •Able to provide informed consent
排除标准
- •Opioid tolerance (more than 60 morphine milliequivalents daily for more than 3 months)
- •Daily gabapentin/pregabalin use for longer than 3 months
- •Prior spine surgery at the index level
- •Allergy or contraindication (including renal, liver disease) to included study medications
- •Patient refusal
结局指标
主要结局
Number of patients who require escalation to (ie, a new prescription for) an opioid-iv-patient controlled analgesia (iv-PCA)
时间窗: First 72 hours after surgery
次要结局
- Numeric rating scale (NRS) pain scores: every 8 hours(Between PACU and 72 hours post surgery)
- Duration of use and dose of opioid-iv-pca (if required)(First 72 hours after surgery)
- Post-operative opioid consumption(From PACU arrival to 72 hours post surgery)
- Duration of ESP catheter(s) use and reasons (if any) for catheter failure or dislodgement(First 48 hours post surgery)
- Opioid-related side effects (nausea, vomiting, anti-emetic medication administration, constipation, sedation, administration of naloxone)(First 48 hours post surgery)
- Quality of Recovery 15 (QoR15) scores(Pre-operative, holding area/day of surgery, 24 hours, 48 hours, 14 days and 42 days post surgery)
- Total dose of ropivacaine delivered(First 48 hours post surgery)
- Length of hospital stay(From PACU arrival to hospital discharge, up to 2 weeks)
- Patient satisfaction scale with pain management and ESP catheters(First 72 hours, 14 days, and 42 days post surgery)
- Incidence of ongoing pain and opioid consumption, measured at 3 and 6 months post-surgery(3 and 6 month post surgery)