Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion
Overview
- Phase
- Early Phase 1
- Intervention
- Blood Test
- Conditions
- Delirium
- Sponsor
- University of Iowa
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Daily Pain Trajectory
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Catherine R. Olinger
Clinical Assistant Professor
University of Iowa
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Arms & Interventions
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Intervention: Blood 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.
Intervention: 3D CAM Delirium Severity Scoring
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Intervention: Generalized Anxiety Disorder 7-item (GAD-7) scale
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Intervention: Numerical Rating Score (NRS)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Intervention: PROMIS-Pain Interference
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Intervention: Oswestry Disability Index (ODI)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Intervention: Saint Louis University Mental Status Examination (SLUMs)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Intervention: Delirium Rating Scale-Revised-98 (DRS)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Intervention: Fear Avoidance Beliefs Questionnaire (FABQ)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Intervention: Telephone Interview for Cognitive Status - Modified (TICS-M)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Intervention: Opioid Equivalents measured by Morphine Milligram Equivalents (MME)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Intervention: Patient Health Questionnaire depression scale (PHQ-8)
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Intervention: Pain Catastrophizing
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Intervention: Opioid Side Effects and Likeability Questionnaire
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Intervention: Daily Pain Trajectory
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Intervention: Tampa Scale of Kinesiophobia
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Intervention: Quality of Recovery 15
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.
Intervention: Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
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.
Intervention: Blood 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.
Intervention: 3D CAM Delirium Severity Scoring
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.
Intervention: Generalized Anxiety Disorder 7-item (GAD-7) scale
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.
Intervention: Numerical Rating Score (NRS)
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.
Intervention: PROMIS-Pain Interference
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.
Intervention: Oswestry Disability Index (ODI)
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.
Intervention: Saint Louis University Mental Status Examination (SLUMs)
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.
Intervention: Delirium Rating Scale-Revised-98 (DRS)
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.
Intervention: Telephone Interview for Cognitive Status - Modified (TICS-M)
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.
Intervention: Opioid Equivalents measured by Morphine Milligram Equivalents (MME)
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.
Intervention: Patient Health Questionnaire depression scale (PHQ-8)
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.
Intervention: Pain Catastrophizing
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.
Intervention: Fear Avoidance Beliefs Questionnaire (FABQ)
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.
Intervention: Opioid Side Effects and Likeability Questionnaire
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.
Intervention: Daily Pain Trajectory
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.
Intervention: Tampa Scale of Kinesiophobia
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.
Intervention: Quality of Recovery 15
Outcomes
Primary Outcomes
Daily Pain Trajectory
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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.)