Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion

Study Overview
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Brief Summary
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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.

Official Title
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Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion

Conditions
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Delirium, Pain, Back, Spinal Fusion, Thoracolumbar Interfascial Plane Block

Intervention / Treatment
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* Drug: Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
* Diagnostic Test: Blood Test
* Other: 3D CAM Delirium Severity Scoring
* Other: Generalized Anxiety Disorder 7-item (GAD-7) scale
* Other: Numerical Rating Score (NRS)
* Other: PROMIS-Pain Interference
* Other: Oswestry Disability Index (ODI)
* Other: Saint Louis University Mental Status Examination (SLUMs)
* Other: Delirium Rating Scale-Revised-98 (DRS)
* Other: Telephone Interview for Cognitive Status - Modified (TICS-M)
* Other: Opioid Equivalents measured by Morphine Milligram Equivalents (MME)
* Other: Patient Health Questionnaire depression scale (PHQ-8)
* Other: Pain Catastrophizing
* Other: Fear Avoidance Beliefs Questionnaire (FABQ)
* Other: Opioid Side Effects and Likeability Questionnaire
* Other: Daily Pain Trajectory
* Other: Tampa Scale of Kinesiophobia
* Other: Quality of Recovery 15


Participation Criteria
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Eligibility Criteria
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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 BMI>40 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.<br>Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine. | Diagnostic Test: Blood Test<br>* Blood Tests measuring inflammatory markers: IL-10, MCP-1, IL-8, IL-6, TNFa<br>Other: 3D CAM Delirium Severity Scoring<br>* Questionnaire that will rate each symptom of delirium<br>Other: Generalized Anxiety Disorder 7-item (GAD-7) scale<br>* Questionnaire for screening and severity measurement of generalized anxiety disorder.<br>Other: Numerical Rating Score (NRS)<br>* Questionnaire assessing pain intensity<br>Other: PROMIS-Pain Interference<br>* Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.<br>Other: Oswestry Disability Index (ODI)<br>* Questionnaire assessing disability and quality of life impairment in adults with lower back pain.<br>Other: Saint Louis University Mental Status Examination (SLUMs)<br>* Questionnaire assessing baseline cognition.<br>Other: Delirium Rating Scale-Revised-98 (DRS)<br>* 16 item clinician rated scale assessing delirium severity.<br>Other: Telephone Interview for Cognitive Status - Modified (TICS-M)<br>* Telephone interview questionnaire evaluating patient cognitive status.<br>Other: Opioid Equivalents measured by Morphine Milligram Equivalents (MME)<br>* The amount of opioids administered will be collected through patient self-report<br>Other: Patient Health Questionnaire depression scale (PHQ-8)<br>* Questionnaire used to diagnose and determine the severity measure for depressive disorders.<br>Other: Pain Catastrophizing<br>* Scale used to determine pain catastrophizing and it's severity.<br>Other: Fear Avoidance Beliefs Questionnaire (FABQ)<br>* Questionnaire used to help predict patients that have a high pain avoidance behavior.<br>Other: Opioid Side Effects and Likeability Questionnaire<br>* Survey determining adverse events related to opioid side effects and complications.<br>Other: Daily Pain Trajectory<br>* Questionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate.<br>Other: Tampa Scale of Kinesiophobia<br>* Questionnaire assessing Kinesiophobia<br>Other: Quality of Recovery 15<br>* Questionnaire assessing postoperative quality of recovery<br>|
| Experimental: Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine<br>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<br>* Patient receives standard of care anesthesia with TLIP Block of bupivicaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.<br>Diagnostic Test: Blood Test<br>* Blood Tests measuring inflammatory markers: IL-10, MCP-1, IL-8, IL-6, TNFa<br>Other: 3D CAM Delirium Severity Scoring<br>* Questionnaire that will rate each symptom of delirium<br>Other: Generalized Anxiety Disorder 7-item (GAD-7) scale<br>* Questionnaire for screening and severity measurement of generalized anxiety disorder.<br>Other: Numerical Rating Score (NRS)<br>* Questionnaire assessing pain intensity<br>Other: PROMIS-Pain Interference<br>* Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.<br>Other: Oswestry Disability Index (ODI)<br>* Questionnaire assessing disability and quality of life impairment in adults with lower back pain.<br>Other: Saint Louis University Mental Status Examination (SLUMs)<br>* Questionnaire assessing baseline cognition.<br>Other: Delirium Rating Scale-Revised-98 (DRS)<br>* 16 item clinician rated scale assessing delirium severity.<br>Other: Telephone Interview for Cognitive Status - Modified (TICS-M)<br>* Telephone interview questionnaire evaluating patient cognitive status.<br>Other: Opioid Equivalents measured by Morphine Milligram Equivalents (MME)<br>* The amount of opioids administered will be collected through patient self-report<br>Other: Patient Health Questionnaire depression scale (PHQ-8)<br>* Questionnaire used to diagnose and determine the severity measure for depressive disorders.<br>Other: Pain Catastrophizing<br>* Scale used to determine pain catastrophizing and it's severity.<br>Other: Fear Avoidance Beliefs Questionnaire (FABQ)<br>* Questionnaire used to help predict patients that have a high pain avoidance behavior.<br>Other: Opioid Side Effects and Likeability Questionnaire<br>* Survey determining adverse events related to opioid side effects and complications.<br>Other: Daily Pain Trajectory<br>* Questionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate.<br>Other: Tampa Scale of Kinesiophobia<br>* Questionnaire assessing Kinesiophobia<br>Other: Quality of Recovery 15<br>* Questionnaire assessing postoperative quality of recovery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Score | Change in pain will be assessed using the Numerical Rating Score Questionnaire immediately before surgery and at 2, 6 and 12 weeks post-operatively. | Change assessed from pre-surgery to 12 weeks post-operatively. | 
| Daily Pain Trajectory | Change in pain will be assessed using the Daily Pain Trajectory survey each day post-operatively for 30 days. | Change assessed from 1 day to 30 days post-operatively | 
| Pain Catastrophizing | 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. | Change from Pre-operation score to 12 weeks post-operatively | 
| Pain Fear and Avoidance | 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. | Change from Pre-operation score to 12 weeks post-operatively | 
| Pain Interference | 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. | Change from Pre-operation score to 12 weeks post-operatively | 
| Generalized Anxiety Disorder | 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. | Change from pre-operation score to 12 weeks post-operatively | 
| Personal Health Questionnaire Depression Scale | 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. | Change from pre-operation score to 12 weeks post-operatively | 
| Oswestry disability index | 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. | Change from Pre-operative score to 12 weeks post-operatively | 
| Tampa Scale of Kinesiophobia | 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. | Change from Pre-operative score to 12 weeks post-operatively | 
| Delirium Rating Scale-Revised-98 | 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. | Change from Pre-operative score to 12 weeks post-operatively | 
| 3D-CAM-S and 3D-CAM-ICU | 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. | Change from Pre-operative score to 12 weeks post-operatively | 
| Modified Telephone Interview of Cognitive Status | 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. | Change from Pre-operative score to 12 weeks post-operatively | 
| Saint Louis University Mental Status Examination (SLUMs) | 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. | Change from Pre-operative score to 12 weeks post-operatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Use | Opioid use will be calculated pre- and post-operatively using the Morphine Milligram Equivalents from patient self-reports. | Change from pre-operative score through 12 weeks post-operatively | 
| Opioid Side Effects and Likability Questionnaire | 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. | Change from 1 week post-operative results to 4 weeks post-operation. | 
| Self-reported Adverse Events | 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 | Change from pre-operative result through 12 weeks post-operatively. | 
| Length of Hospitalization | The length of time patients were hospitalized will be collected through the electronic health record. | Through study completion, 16 months | 
| Disposition to skilled-facilities | Where patients are dispositioned post-operatively will be collected through the electronic health record. | Through study completion, 16 months | 
| 90-day Readmission Rates | The 90-day readmission rates will be collected through the electronic health record. | Through study completion, 16 months | 
| Blood test for Inflammation | Blood test for IL-10, MCP-1, NfL, IL-6, and IL-8 will be done pre- and post-surgery for presence and levels of IL-10, MCP-1, NfL, IL-6, and IL-8. | Measured Immediately before surgery and 1 day post-operatively |