Investigational Plan for the Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Pain (Mean VAS pain score at 24 hours post-procedure)
研究概览
简要总结
The purpose of this study is to evaluate the clinical performance of the ReLeaf infusion catheter & wound drain in patients following lumbar spinal fusion surgery. One half of the patients will receive continuous local analgesic fusion during the post-operative period while the other half will received continuous local saline.
详细描述
Posterior lumbar spinal fusion is commonly used in the management of a wide array of spinal disorders ranging from instability to degenerative disc disease. However, severe postoperative pain is a significant adverse outcome in patients who have undergone a lumbar spinal fusion procedure. This pain may delay mobilization and decrease compliance with physical, occupational, or pulmonary physiotherapy.
Pain symptoms may worsen with activity and ambulation due to reflex spasms of the paraspinal muscles elicited by pain from the wound. A local anesthetic agent administered immediately after surgery into the tissue surrounding the wound addresses the pain source for less than four hours. Therefore, it is reasonable to consider continuous local anesthetic infusion, which may limit local pain mediators for a longer duration.
Continuous local anesthetic infusion into the paraspinal musculature with the ReLeaf catheter has the potential to reduce pain, narcotic demand & usage, and accelerate the rate of recovery in lumbar spinal fusion patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature
- •Diagnosis of lumbar spine disease requiring an open, midline, instrumented posterolateral fusion with or without interbody support at one or two vertebral levels and laminectomy or laminotomy
- •Physically and mentally willing to comply with the study requirements
- •Signed the study informed consent
排除标准
- •Lumbar spine disease requiring more than two levels of instrumentation
- •Any previous operative lumbar procedure, except discectomy or hemi-laminotomy performed a minimum of 2 years prior to current study surgery
- •Patients requiring iliac crest bone graft for the procedure
- •Intra-operative durotomy
- •Any duration of pre-operative morphine or morphine equivalent use exceeding 30 mg of morphine equivalents per day for longer than 3 months
- •Physically or mentally compromised (i.e., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or substance abuse)
- •Diagnosed with Severe Depression and on treatment
- •Active infection at the operative level or a symptomatic infection
- •Diagnosed systemic disease that would affect the subject's welfare or overall outcome of the research study (i.e. Paget's disease, renal osteodystrophy, Lupus etc)
- •Is pregnant or breast feeding
- •Has any active malignancy or spinal arthrodesis being performed for a tumor decompression
- •Has a known allergy to local analgesics
- •Pending litigation related to back pain or injury or Worker's Compensation
研究组 & 干预措施
Ropivacaine
Continuous 0.2% Ropivacaine infusion until catheter removal (typically 36 hours)
干预措施: Morphine (Drug)
Ropivacaine
Continuous 0.2% Ropivacaine infusion until catheter removal (typically 36 hours)
干预措施: ReLeaf catheter (Device)
Ropivacaine
Continuous 0.2% Ropivacaine infusion until catheter removal (typically 36 hours)
干预措施: Ropivacaine (Drug)
Ropivacaine
Continuous 0.2% Ropivacaine infusion until catheter removal (typically 36 hours)
干预措施: Oxycodone (Drug)
Saline
Continuous saline infusion until catheter removal (typically 36 hours)
干预措施: ReLeaf catheter (Device)
Saline
Continuous saline infusion until catheter removal (typically 36 hours)
干预措施: Saline (Drug)
Saline
Continuous saline infusion until catheter removal (typically 36 hours)
干预措施: Morphine (Drug)
Saline
Continuous saline infusion until catheter removal (typically 36 hours)
干预措施: Oxycodone (Drug)
结局指标
主要结局
Pain (Mean VAS pain score at 24 hours post-procedure)
时间窗: 24 hours
Mean VAS pain score at 24 hours post-procedure
次要结局
- Adverse Events(3 months)
- Medication Use(3 months)