Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Acceptability of study procedures and intervention: attrition (reasons)
研究概览
简要总结
The goal of this pilot clinical trial is to test the feasibility of conducting a randomized controlled trial that will examine the use of ropivacaine in the spinal anesthesia for patients undergoing elective 1- or 2-level lower spine surgery. This study aims to:
- Determine the rates of eligibility, recruitment, consent, and attrition
- Determine the acceptability among patients, surgeons, anesthesiologists, and nurses of doing spine surgery under spinal anesthesia
- Gather preliminary data on outcomes relevant to a future dose-finding study
Participants will be randomized to one of three treatment groups:
- General anesthesia with endotracheal tube
- Spinal anesthesia with bupivacaine
- Spinal anesthesia with ropivacaine
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
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who are equal to or greater than 18 years old
- •Undergoing elective one or two-level lumbar surgery via posterior surgical approach in the prone position (between L2-S1)
- •Expected surgery duration of no greater than 2 hours
- •ASA Physical Status Class 1 to 3
- •Patient can have either spinal anesthesia or general anesthesia
- •Able to provide consent and understand information in English, and capable of answering questions in English
排除标准
- •Allergy to either ropivacaine, bupivacaine, or local anesthetics
- •Contraindications to spinal anesthesia (i.e. coagulopathy or on anticoagulants, severe aortic or mitral valve stenosis, sepsis or bacteremia, thrombocytopenia, high intracranial pressure, infection at the puncture site)
- •Surgery is expected to take more than 2 hours
- •Emergency surgery
- •Previously had back surgery at the level of the spine currently being operated on
- •Comorbidities that require the patient to undergo general anesthesia
- •Inability to stay still during the surgery
- •Inability to move legs preoperatively
- •Body Mass Index (BMI) >35
- •Multilevel severe spinal stenosis
研究组 & 干预措施
General anesthesia with endotracheal tube
Currently the standard at our centre. Participants in this group will undergo lower lumbar surgery with general anesthesia with endotracheal intubation.
干预措施: General anesthesia for lumbar surgery (Drug)
结局指标
主要结局
Acceptability of study procedures and intervention: attrition (reasons)
时间窗: Study duration, until last patient has completed the study (average of 1 year)
Reasons why the patient, neurosurgeon and/or anesthesiologist refused to proceed with the patient's pilot study participation
Acceptability of study procedures and intervention: eligibility and recruitment
时间窗: Study duration, until last patient has completed the study (average of 1 year)
Number of patients contacted who accepted or declined to participate in the study, with the acceptance rate calculated as the percentage of contacted patients who agreed to participate in the study
Acceptability of study procedures and intervention: attrition
时间窗: Study duration, until last patient has completed the study (average of 1 year)
Number of patients who complete the study after randomization, with the completion rate calculated as the percentage of randomized patients in whom we were able to collect the Quality of Recovery-15 survey results
Determining the success of our randomization procedures: as per protocol
时间窗: Study duration, until last patient has completed the study (average of 1 year)
Number of participants who actually get the intervention assigned to them, calculated as the percentage of randomized patients who receive the anesthetic protocol assigned to them
Determining the success of our randomization procedures: randomization process
时间窗: Study duration, until last patient has completed the study (average of 1 year)
Similarity of the groups on their baseline characteristics based on the demographic information
次要结局
- Preliminary outcome data: surgery abandonment rate(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: neurosurgeon's experience with conducting neurosurgery under neuraxial technique, and reasons(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: height of sensory block after intrathecal administration of study medications(Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: motor block after intrathecal administration of study medications(Intraoperative and postoperative up to discharge (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: density of sensory block after intrathecal administration of study medications(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: total dosages of analgesics and sedatives ((Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: vasopressor requirements(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: pain scores(Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: bradycardia(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: time(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: number of attempts for the anesthesiologist to administer intrathecal medications(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: hypotension(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: postanesthetic care unit (PACU) nurses' workload experience with conducting neurosurgery under neuraxial technique(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: patient's memory during surgery(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: completion rate(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: operating room nurses' experience with conducting neurosurgery under neuraxial technique(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: patient's experience during spinal anesthesia administration(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: operating room nurses' workload experience with conducting neurosurgery under neuraxial technique(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: postanesthetic care unit (PACU) nurses' experience(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: patient's preference preoperatively(Preoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: neurosurgeon's experience with conducting neurosurgery under neuraxial technique(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: patient's comfort during surgery(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: patient's Quality of Recovery (QoR-15)(Postoperative (per patient); study duration after last patient has completed the study (24 hours after surgery) (average of 1 year))
- Preliminary outcome data: anesthesiologist's workload when conducting neurosurgery under spinal anesthesia(Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year))
- Preliminary outcome data: patient's discomfort with numbness or weakness postoperatively(Postoperative (per patient); study duration after last patient has completed the study (average of 1 year))
研究者
Alan Tung
Clinical Instructor
Fraser Health