Intrathecal Morphine vs Intrathecal Morphine Combined With Clonidine for 1-2 Level Lumbar Fusion
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- MaineHealth
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Post-operative opioid consumption
研究概览
简要总结
Dr. Parker Merrill (anesthesiologist) and Dr. Chris Neal (neurosurgeon) are working on a research study comparing two methods of pain control for patients having spinal fusion surgery.
We are looking for English-speaking patients between 18 and 70 years old who are scheduled for 1-2 level lumbar spine fusion surgery.
Participants in this study will either get morphine injected during surgery (current pain treatment) or morphine and another drug, clonidine. There is an equal chance of getting the two treatment options. No matter which group you are assigned to, you will be provided with additional pain medication if needed after your surgery.
You may not directly benefit from participating in this study, but you might have an improvement in your pain after surgery. You will also be helping researchers and doctors find better pain control options for future patients.
详细描述
The purpose of this study is to try to improve the medications we give to patients to help with their pain after surgery. Many positive changes have been made over the years, but there remains room for improvement. Lumbar spine surgery allows for easy access to the intrathecal space (the fluid around the spinal cord, or CSF) where medications can be given to directly work on pain receptors in the spinal cord. We know that two medications, morphine and clonidine, can be helpful for pain relief when given into the CSF. Our hypothesis is that adding clonidine and morphine together may offer better pain control than just morphine alone. We hope this study will give us more pain-control options for patients having spine surgery.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 四盲 (受试者、医护人员、研究者、结局评估者)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 18-70 years of age
- Scheduled for 1-2 level lumbar fusion
- Expected post-operative inpatient stay of at least 24 hours
- ASA I-III
- English speaking
排除标准
- Substance use disorder
- Chronic pain (opioid use of 90 MME daily prior to surgery)
- BMI > 40
- Allergies to clonidine or morphine
- Emergent surgery
- Coagulopathy (INR >1.5)
- Platelet count <80
- Significant cardiovascular disease
- baseline systolic blood pressure <100
- Patients on clonidine prior to surgery
- Patients scheduled for a revision surgical procedure
- Patients who are unable to give informed consent
- Pregnant patients
- Prisoners
研究组 & 干预措施
Intrathecal Morphine + Intrathecal Clonidine
Participants in this group will receive the experimental treatment; the standard of care with the addition of 75 mcg of intrathecal clonidine.
干预措施: Intrathecal Morphine + Intrathecal Clonidine (Drug)
Intrathecal Morphine
Participants in this group will receive the current standard of care.
干预措施: Intrathecal Morphine (Drug)
结局指标
主要结局
Post-operative opioid consumption
时间窗: 24 hours post-op
Post-operative opioid consumption measured as morphine milligram equivalents (MME)
次要结局
- Pain scores(72 hours post-op)
- Post-operative opioid consumption(72 hours post-op)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07846657
- 其他研究编号
- STUDY00000209
日期
- 首次提交
- (8天前)
- 首次发布
- (昨天)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
Deidentified IPD relating to primary and secondary outcomes will be made available following IRB approval and execution of a data sharing agreement.