Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Time to residual motor blockade reversal
研究概览
简要总结
The purpose of this study is to determine the feasibility of administering a predetermined amount of normal saline into the intrathecal or subarachnoid space via a small spinal catheter to reduce or eliminate the effects of previously injected spinal anesthetic following lower extremity orthopedic surgery.
详细描述
This is a prospective, randomized, interventional study to assess the feasibility and effectiveness of administering normal saline into the intrathecal or subarachnoid space through a small gauge epidural catheter via a single spinal needle to reverse residual anesthesia following lower extremity orthopedic surgery. This method is adapted from observations in obstetric populations where saline administered via the spinal catheter reduced headaches. This study investigates whether orthopedic patients will also receive unique benefits.
Research procedures overview:
- Randomization to intervention or control arm,
- Use of 6-inch BD 20-gauge Quincke spinal needle, through which a B. Braun Perifix 24-gauge polyurethane catheter
- Administration of normal saline
- Administration of post-operative survey while in the PACU
- Medical record review and abstraction.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having elective lower extremity joint replacement surgery
- •Patients >18 years
排除标准
- •Contraindications to spinal anesthesia (refusal, lumbar spinal hardware, spinal abnormalities)
- •Patient on anticoagulation not withheld
- •Patient receiving re-operation on the same joint
- •Prior intra-cranial bleeding
- •Patient's ASA status >3
- •Non-English speaking
- •Bromage score of 6 at the time of first PACU assessment post-enrollment
研究组 & 干预措施
Control
Patients randomized to the control group will receive a combined spinal intrathecal catheter and the same dosing of spinal medications. All aspects of care and monitoring will be the same as non-study patients. The control group will not receive a dose of intrathecal saline post-op
Saline administered via the intrathecal catheter
Patients randomized to the Intervention group will be administered 10ml of sterile normal saline via the intrathecal catheter post-op prior to catheter removal.
干预措施: Normal Saline 10 mL Injection (Drug)
结局指标
主要结局
Time to residual motor blockade reversal
时间窗: Initiation of spinal anesthetic to reversal, up to sixty minutes after removal of catheter.
Time to residual motor blockade reversal as measured by Bromage score following saline administration and catheter removal, up to a maximum of 60 minutes.
次要结局
未报告次要终点
研究者
Joan Spiegel
Principal Investigator
Beth Israel Deaconess Medical Center