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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05461092
• Other study ID #: 202305284
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 1, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: University of Iowa
• Contact: Alex R Coffman, BS
• Phone: 319-353-8996
• Email: alex-coffman[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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, IL-8, IL-6, TNFa

Other:
• 3D CAM Delirium Severity Scoring
Questionnaire that will rate each symptom of delirium
• Generalized Anxiety Disorder 7-item (GAD-7) scale
Questionnaire for screening and severity measurement of generalized anxiety disorder.
• Numerical Rating Score (NRS)
Questionnaire assessing pain intensity
• PROMIS-Pain Interference
Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.
• Oswestry Disability Index (ODI)
Questionnaire assessing disability and quality of life impairment in adults with lower back pain.
• Saint Louis University Mental Status Examination (SLUMs)
Questionnaire assessing baseline cognition.
• Delirium Rating Scale-Revised-98 (DRS)
16 item clinician rated scale assessing delirium severity.
• Telephone Interview for Cognitive Status - Modified (TICS-M)
Telephone interview questionnaire evaluating patient cognitive status.
• Opioid Equivalents measured by Morphine Milligram Equivalents (MME)
The amount of opioids administered will be collected through patient self-report
• Patient Health Questionnaire depression scale (PHQ-8)
Questionnaire used to diagnose and determine the severity measure for depressive disorders.
• Pain Catastrophizing
Scale used to determine pain catastrophizing and it's severity.
• Fear Avoidance Beliefs Questionnaire (FABQ)
Questionnaire used to help predict patients that have a high pain avoidance behavior.
• Opioid Side Effects and Likeability Questionnaire
Survey determining adverse events related to opioid side effects and complications.
• Daily Pain Trajectory
Questionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate.
• Tampa Scale of Kinesiophobia
Questionnaire assessing Kinesiophobia
• Quality of Recovery 15
Questionnaire assessing postoperative quality of recovery

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

References & Publications (49)

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* Note: There are 49 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	Length of Hospitalization	The length of time patients were hospitalized will be collected through the electronic health record.	Through study completion, 16 months
Secondary	Disposition to skilled-facilities	Where patients are dispositioned post-operatively will be collected through the electronic health record.	Through study completion, 16 months
Secondary	90-day Readmission Rates	The 90-day readmission rates will be collected through the electronic health record.	Through study completion, 16 months
Secondary	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