Regional Nerve Blocks to Reduce Opioid Use and Complications in Older Adults Undergoing Spinal Fusion
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine. Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine. |
Diagnostic Test: Blood Test
Blood Tests measuring inflammatory markers: IL-10, MCP-1, NfL
Other: 3D CAM Delirium Severity Scoring
Questionnaire that will rate each symptom of delirium
Other: Generalized Anxiety Disorder 7-item (GAD-7) scale
Questionnaire for screening and severity measurement of generalized anxiety disorder.
Other: Numerical Rating Score (NRS)
Questionnaire assessing pain intensity
Other: PROMIS-Pain Interference
Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.
Other: Oswestry Disability Index (ODI)
Questionnaire assessing disability and quality of life impairment in adults with lower back pain.
Other: Saint Louis University Mental Status Examination (SLUMs)
Questionnaire assessing baseline cognition.
Other: Delirium Rating Scale-Revised-98 (DRS)
16 item clinician rated scale assessing delirium severity.
Other: Telephone Interview for Cognitive Status - Modified (TICS-M)
Telephone interview questionnaire evaluating patient cognitive status.
Other: Opioid Equivalents measured by Morphine Milligram Equivalents (MME)
The amount of opioids administered will be collected through patient self-report
Other: Patient Health Questionnaire depression scale (PHQ-8)
Questionnaire used to diagnose and determine the severity measure for depressive disorders.
Other: Pain Catastrophizing
Scale used to determine pain catastrophizing and it's severity.
Other: Fear Avoidance Beliefs Questionnaire (FABQ)
Questionnaire used to help predict patients that have a high pain avoidance behavior.
Other: Opioid Side Effects and Likeability Questionnaire
Survey determining adverse events related to opioid side effects and complications.
Other: Daily Pain Trajectory
Questionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate.
Other: Tampa Scale of Kinesiophobia
Questionnaire assessing Kinesiophobia
|
| Experimental: 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. |
Drug: Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivicaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Diagnostic Test: Blood Test
Blood Tests measuring inflammatory markers: IL-10, MCP-1, NfL
Other: 3D CAM Delirium Severity Scoring
Questionnaire that will rate each symptom of delirium
Other: Generalized Anxiety Disorder 7-item (GAD-7) scale
Questionnaire for screening and severity measurement of generalized anxiety disorder.
Other: Numerical Rating Score (NRS)
Questionnaire assessing pain intensity
Other: PROMIS-Pain Interference
Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.
Other: Oswestry Disability Index (ODI)
Questionnaire assessing disability and quality of life impairment in adults with lower back pain.
Other: Saint Louis University Mental Status Examination (SLUMs)
Questionnaire assessing baseline cognition.
Other: Delirium Rating Scale-Revised-98 (DRS)
16 item clinician rated scale assessing delirium severity.
Other: Telephone Interview for Cognitive Status - Modified (TICS-M)
Telephone interview questionnaire evaluating patient cognitive status.
Other: Opioid Equivalents measured by Morphine Milligram Equivalents (MME)
The amount of opioids administered will be collected through patient self-report
Other: Patient Health Questionnaire depression scale (PHQ-8)
Questionnaire used to diagnose and determine the severity measure for depressive disorders.
Other: Pain Catastrophizing
Scale used to determine pain catastrophizing and it's severity.
Other: Fear Avoidance Beliefs Questionnaire (FABQ)
Questionnaire used to help predict patients that have a high pain avoidance behavior.
Other: Opioid Side Effects and Likeability Questionnaire
Survey determining adverse events related to opioid side effects and complications.
Other: Daily Pain Trajectory
Questionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate.
Other: Tampa Scale of Kinesiophobia
Questionnaire assessing Kinesiophobia
|
Outcome Measures
Primary Outcome Measures
- Numerical Rating Score [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.
- Daily Pain Trajectory [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.
- Pain Catastrophizing [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.
- Pain Fear and Avoidance [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 [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.
- Generalized Anxiety Disorder [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.
- Personal Health Questionnaire Depression Scale [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.
- Oswestry disability index [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.
- Tampa Scale of Kinesiophobia [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.
- Delirium Rating Scale-Revised-98 [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 [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.
- Modified Telephone Interview of Cognitive Status [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) [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.
Secondary Outcome Measures
- Opioid Use [Change from pre-operative score through 12 weeks post-operatively]
Opioid use will be calculated pre- and post-operatively using the Morphine Milligram Equivalents from patient self-reports.
- Opioid Side Effects and Likability Questionnaire [Change from 1 week post-operative results to 4 weeks post-operation.]
Change in adverse events related to opioid side effects and complications will be assessed using the Opioid Side Effects and Likeability Questionnaire measured 1 week and 4 weeks post-operatively.
- Self-reported Adverse Events [Change from pre-operative result through 12 weeks post-operatively.]
Change in adverse events related to opioid use and post-surgical outcomes will be collected post-operatively through the electronic health record from patient self-report. This will be measured immediately before surgery and 1, 2, 4, 6, and 12 weeks post-operatively
- Length of Hospitalization [Through study completion, 16 months]
The length of time patients were hospitalized will be collected through the electronic health record.
- Disposition to skilled-facilities [Through study completion, 16 months]
Where patients are dispositioned post-operatively will be collected through the electronic health record.
- 90-day Readmission Rates [Through study completion, 16 months]
The 90-day readmission rates will be collected through the electronic health record.
- Blood test for Inflammation [Measured Immediately before surgery and 1 day post-operatively]
Blood test for IL-10, MCP-1, and NfL will be done pre- and post-surgery for presence and levels of IL-10, MCP-1, and NfL.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Are 65 or older
-
Indicated for lumbar spinal fusion of less than or equal to 3 levels
Exclusion Criteria:
-
64 years old and younger
-
emergency treatment
-
pathologic fractures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Iowa | Iowa City | Iowa | United States | 52242 |
Sponsors and Collaborators
- University of Iowa
Investigators
- Principal Investigator: Catherine R Olinger, MD, Clinical Assistant Professor
Study Documents (Full-Text)
None provided.More Information
Publications
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