Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Daily Pain Trajectory
研究概览
简要总结
This initial study is a feasibility study for implementing thoracolumbar interfascial plane, or TLIP, blocks in older adults undergoing spinal fusion. TLIP blocks are done by using anesthesia. In this case, it will be done to either side of the back where surgery will be performed. This has been shown to decrease pain the patients have post-operatively in previous research. In this study, the investigators will examine recruitment rates, completion of assessments, dropout rate, gather patient feedback, and identify barriers to performing TLIP. Further, this feasibility study will provide data to determine adequate sample size and refine methods and outcomes for a future randomized clinical trial. The ultimate goal is to perform a large, appropriately powered randomized control trial to determine the effect of TLIP blocks on pain, physical function and disability, opioid consumption, and delirium in older adult undergoing spinal fusion.
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
- Double (Participant, Investigator)
盲法说明
Both patient (participant) and surgeon will be masked
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are 65 or older
- •Indicated for lumbar spinal fusion of less than or equal to 3 levels
- •Undergoing elective surgery
- •no contraindications to local anesthetic or procedures
- •no severe cardiac or respiratory disease
- •no preexisting cognitive dysfunction/dementia
排除标准
- •64 years old and younger
- •emergency treatment
- •pathologic fractures
- •seeking revision surgery
- •major liver or kidney dysfunction
- •coexisting hematological disorder or irreversible abnormal coagulation
- •patients with previous diagnosis of dementia or SLUMS score <20
- •patient unable to communicate/cooperate/language barrier
- •allergy to study medications
- •opioid tolerant (oral opioid intake morphine equivalent =< 60 mg/day)
- •other sources of chronic pain like fibromyalgia
- •patients with associated significant CNS or respiratory disease (home oxygen requirements)
- •incarcerated patients
- •psychiatric illnesses preoperative neurological deficits greater than one motor group, less than three out of five motor functions
- •pregnant or breast feeding
研究组 & 干预措施
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
干预措施: Blood Test (Diagnostic Test)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
干预措施: 3D CAM Delirium Severity Scoring (Other)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
干预措施: Generalized Anxiety Disorder 7-item (GAD-7) scale (Other)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
干预措施: Numerical Rating Score (NRS) (Other)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
干预措施: PROMIS-Pain Interference (Other)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
干预措施: Oswestry Disability Index (ODI) (Other)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
干预措施: Saint Louis University Mental Status Examination (SLUMs) (Other)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
干预措施: Delirium Rating Scale-Revised-98 (DRS) (Other)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
干预措施: Fear Avoidance Beliefs Questionnaire (FABQ) (Other)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
干预措施: Telephone Interview for Cognitive Status - Modified (TICS-M) (Other)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
干预措施: Opioid Equivalents measured by Morphine Milligram Equivalents (MME) (Other)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
干预措施: Patient Health Questionnaire depression scale (PHQ-8) (Other)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
干预措施: Pain Catastrophizing (Other)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
干预措施: Opioid Side Effects and Likeability Questionnaire (Other)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
干预措施: Daily Pain Trajectory (Other)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
干预措施: Tampa Scale of Kinesiophobia (Other)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
干预措施: Quality of Recovery 15 (Other)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine (Drug)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: Blood Test (Diagnostic Test)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: 3D CAM Delirium Severity Scoring (Other)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: Generalized Anxiety Disorder 7-item (GAD-7) scale (Other)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: Numerical Rating Score (NRS) (Other)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: PROMIS-Pain Interference (Other)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: Oswestry Disability Index (ODI) (Other)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: Saint Louis University Mental Status Examination (SLUMs) (Other)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: Delirium Rating Scale-Revised-98 (DRS) (Other)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: Telephone Interview for Cognitive Status - Modified (TICS-M) (Other)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: Opioid Equivalents measured by Morphine Milligram Equivalents (MME) (Other)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: Patient Health Questionnaire depression scale (PHQ-8) (Other)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: Pain Catastrophizing (Other)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: Fear Avoidance Beliefs Questionnaire (FABQ) (Other)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: Opioid Side Effects and Likeability Questionnaire (Other)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: Daily Pain Trajectory (Other)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: Tampa Scale of Kinesiophobia (Other)
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
干预措施: Quality of Recovery 15 (Other)
结局指标
主要结局
Daily Pain Trajectory
时间窗: Change assessed from 1 day to 30 days post-operatively
Change in pain will be assessed using the Daily Pain Trajectory survey each day post-operatively for 30 days.
Numerical Rating Score
时间窗: Change assessed from pre-surgery to 12 weeks post-operatively.
Change in pain will be assessed using the Numerical Rating Score Questionnaire immediately before surgery and at 2, 6 and 12 weeks post-operatively.
Pain Fear and Avoidance
时间窗: Change from Pre-operation score to 12 weeks post-operatively
Change in pain fear and subject avoidance will be assessed using the Pain Fear and Avoidance Questionnaire immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Pain Interference
时间窗: Change from Pre-operation score to 12 weeks post-operatively
Change in how pain interferes with patient physical, emotional, and social functioning will be assessed using the PROMIS - Pain Interference questionnaire immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Oswestry disability index
时间窗: Change from Pre-operative score to 12 weeks post-operatively
Change in disability score will be assessed using the Oswestry disability index measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Generalized Anxiety Disorder
时间窗: Change from pre-operation score to 12 weeks post-operatively
Change in severity measurement of generalized anxiety disorder assessed using the Generalized Anxiety Disorder 7 item scale immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Tampa Scale of Kinesiophobia
时间窗: Change from Pre-operative score to 12 weeks post-operatively
Change in kinesiophobia will be assessed using the Tampa Scale of Kinesiophobia measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Pain Catastrophizing
时间窗: Change from Pre-operation score to 12 weeks post-operatively
Change in pain catastrophizing and severity will be assessed using the Pain Catastrophizing scale immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Personal Health Questionnaire Depression Scale
时间窗: Change from pre-operation score to 12 weeks post-operatively
Change in depression will be assessed using the Personal Health Questionnaire Depression Scale measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Modified Telephone Interview of Cognitive Status
时间窗: Change from Pre-operative score to 12 weeks post-operatively
Change in cognitive status will be assessed using the Modified Telephone Interview of cognitive Status measured immediately before surgery and at 6, and 12 weeks post-operatively.
Saint Louis University Mental Status Examination (SLUMs)
时间窗: Change from Pre-operative score to 12 weeks post-operatively.
Change in baseline cognition will be assessed using the Saint Louis University Mental Status Examination measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Delirium Rating Scale-Revised-98
时间窗: Change from Pre-operative score to 12 weeks post-operatively
Change in delirium severity will be assessed using the Delirium Rating Scale-Revised-98 16 item clinician rated scale measured immediately before surgery and at 1 day, 2 days, 3 days, 2 weeks, 6 weeks, and 12 weeks post-operatively.
3D-CAM-S and 3D-CAM-ICU
时间窗: Change from Pre-operative score to 12 weeks post-operatively
Change in delirium symptoms will be assessed using the 3D-CAM-S and 3D-CAM-ICU Questionnaire measured immediately before surgery and at 1 day, 2 days, 3 days, 2 weeks, 6 weeks, and 12 weeks post-operatively.
次要结局
- Opioid Side Effects and Likability Questionnaire(Change from 1 week post-operative results to 4 weeks post-operation.)
- Length of Hospitalization(Through study completion, 16 months)
- Disposition to skilled-facilities(Through study completion, 16 months)
- 90-day Readmission Rates(Through study completion, 16 months)
- Opioid Use(Change from pre-operative score through 12 weeks post-operatively)
- Blood test for Inflammation(Measured Immediately before surgery and 1 day post-operatively)
- Self-reported Adverse Events(Change from pre-operative result through 12 weeks post-operatively.)
研究者
Catherine R. Olinger
Clinical Assistant Professor
University of Iowa