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

Early Phase 1

Recruiting

• Conditions: Pain, Back; Thoracolumbar Interfascial Plane Block; Delirium; Spinal Fusion
• Interventions: Diagnostic Test: Blood Test; Drug: Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; 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

• Registration Number: NCT05461092
• Lead Sponsor: University of Iowa

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-07-12
• Study First Posted: 2022-07-15
• Study Start: 2024-01-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.	Oswestry Disability Index (ODI)	Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.	Opioid Equivalents measured by Morphine Milligram Equivalents (MME)	Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.	Fear Avoidance Beliefs Questionnaire (FABQ)	Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.	Blood Test	Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.	3D CAM Delirium Severity Scoring	Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.	Telephone Interview for Cognitive Status - Modified (TICS-M)	Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.	Opioid Side Effects and Likeability Questionnaire	Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	3D CAM Delirium Severity Scoring	Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	Numerical Rating Score (NRS)	Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.	Patient Health Questionnaire depression scale (PHQ-8)	Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.	Delirium Rating Scale-Revised-98 (DRS)	Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.	PROMIS-Pain Interference	Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.	Saint Louis University Mental Status Examination (SLUMs)	Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.	Pain Catastrophizing	Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	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.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	Oswestry Disability Index (ODI)	Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.	Generalized Anxiety Disorder 7-item (GAD-7) scale	Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.	Numerical Rating Score (NRS)	Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.	Daily Pain Trajectory	Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.	Tampa Scale of Kinesiophobia	Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	Blood Test	Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	Saint Louis University Mental Status Examination (SLUMs)	Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	Pain Catastrophizing	Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	Opioid Equivalents measured by Morphine Milligram Equivalents (MME)	Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	Patient Health Questionnaire depression scale (PHQ-8)	Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	Tampa Scale of Kinesiophobia	Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	Generalized Anxiety Disorder 7-item (GAD-7) scale	Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	Telephone Interview for Cognitive Status - Modified (TICS-M)	Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.	Quality of Recovery 15	Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	PROMIS-Pain Interference	Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	Fear Avoidance Beliefs Questionnaire (FABQ)	Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	Quality of Recovery 15	Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	Delirium Rating Scale-Revised-98 (DRS)	Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	Daily Pain Trajectory	Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine	Opioid Side Effects and Likeability Questionnaire	Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
Blood test for Inflammation	Measured Immediately before surgery and 1 day post-operatively	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.
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

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States