Pilot Study on the Thermal Effects of Local Anesthetics
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Time to block of pain and thermosensory perception
研究概览
简要总结
This is a pilot study of approximately 20 pre-operative patients scheduled for a transversus abdominis plane (TAP) block as pain management for a previously scheduled surgery. Subjects will be randomly assigned to receive either cooled ropivacaine (4°C) during a TAP block or room temperature (between 20-25°C) ropivacaine during the block. The effects of a TAP block generally diminish within 24 hours. We believe that cooling ropivacaine before administration may slightly prolong the analgesic effects of the block and delay time before additional analgesic is requested, resulting in less opioid use following surgery.
详细描述
After consenting, subjects will be randomized to receive either cooled ropivacaine, administered at approximately 4°C) or room temperature ropivacaine, administered at approximately 20-25°C), during an ultrasound-guided TAP block. Time to anesthesia, or loss of sensation, will be recorded for each subject by a single evaluator, employing the pinch technique and thermosensory perception, using a glove, filled with a slurry of ice water placed on both anesthetized and non-anesthetized areas, for approximately 5 seconds. Time to anesthesia will be recorded when there is a definitive difference on a categorical scale (painful/not painful or cold/not cold) as measured by the subject, between the anesthetized and non-anesthetized areas. Safety outcomes and opioid morphine equivalency will be recorded for all subjects, for approximately 48 hours following surgery.
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
- 否
入选标准
- •Patients, aged =18 years of age.
- •Patients, scheduled for surgery, with an order for a TAP block.
排除标准
- •Patients with a history of opioid use disorder.
- •Patients, which are scheduled as the first case of the day.
- •Patients with any history of paralysis/palsy.
- •Patients with a history of sensitivity to local anesthetics, including ropivacaine.
- •Patients, whose blocks are scheduled to be administered by a PGY-1 or PGY-2 resident.
研究组 & 干预措施
Cool Block
Ropivacaine administered at approximately 4C, via a TAP block.
干预措施: Cool Ropivacaine Block (Drug)
Room Temp Block
Ropivacaine administered at approximately 20-25C, via a TAP block.
干预措施: Room Temp Ropivacaine Block (Drug)
结局指标
主要结局
Time to block of pain and thermosensory perception
时间窗: 35 minutes
次要结局
- Morphine equivalency units of adjunct pain medications(24 hours)
研究者
Daniel Wambold
Study Principal Investigator
University of Kentucky