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

Primary Purpose

Delirium, Pain, Back, Spinal Fusion

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Blood Test
3D CAM Delirium Severity Scoring
Generalized Anxiety Disorder 7-item (GAD-7) scale
Numerical Rating Score (NRS)
PROMIS-Pain Interference
Oswestry Disability Index (ODI)
Saint Louis University Mental Status Examination (SLUMs)
Delirium Rating Scale-Revised-98 (DRS)
Telephone Interview for Cognitive Status - Modified (TICS-M)
Opioid Equivalents measured by Morphine Milligram Equivalents (MME)
Patient Health Questionnaire depression scale (PHQ-8)
Pain Catastrophizing
Fear Avoidance Beliefs Questionnaire (FABQ)
Opioid Side Effects and Likeability Questionnaire
Daily Pain Trajectory
Tampa Scale of Kinesiophobia
Quality of Recovery 15
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine

Arm Description

Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.

Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.

Outcomes

Primary Outcome Measures

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.
Daily Pain Trajectory
Change in pain will be assessed using the Daily Pain Trajectory survey each day post-operatively for 30 days.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Opioid Use
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 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 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
The length of time patients were hospitalized will be collected through the electronic health record.
Disposition to skilled-facilities
Where patients are dispositioned post-operatively will be collected through the electronic health record.
90-day Readmission Rates
The 90-day readmission rates will be collected through the electronic health record.
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.

Full Information

First Posted
June 20, 2022
Last Updated
October 23, 2023
Sponsor
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT05461092
Brief Title
Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion
Official Title
Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Pain, Back, Spinal Fusion, Thoracolumbar Interfascial Plane Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Both patient (participant) and surgeon will be masked
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Arm Type
Active Comparator
Arm Description
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Arm Title
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Arm Type
Experimental
Arm Description
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Intervention Type
Drug
Intervention Name(s)
Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Intervention Description
Patient receives standard of care anesthesia with TLIP Block of bupivicaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood Test
Intervention Description
Blood Tests measuring inflammatory markers: IL-10, MCP-1, IL-8, IL-6, TNFa
Intervention Type
Other
Intervention Name(s)
3D CAM Delirium Severity Scoring
Intervention Description
Questionnaire that will rate each symptom of delirium
Intervention Type
Other
Intervention Name(s)
Generalized Anxiety Disorder 7-item (GAD-7) scale
Intervention Description
Questionnaire for screening and severity measurement of generalized anxiety disorder.
Intervention Type
Other
Intervention Name(s)
Numerical Rating Score (NRS)
Intervention Description
Questionnaire assessing pain intensity
Intervention Type
Other
Intervention Name(s)
PROMIS-Pain Interference
Intervention Description
Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.
Intervention Type
Other
Intervention Name(s)
Oswestry Disability Index (ODI)
Intervention Description
Questionnaire assessing disability and quality of life impairment in adults with lower back pain.
Intervention Type
Other
Intervention Name(s)
Saint Louis University Mental Status Examination (SLUMs)
Intervention Description
Questionnaire assessing baseline cognition.
Intervention Type
Other
Intervention Name(s)
Delirium Rating Scale-Revised-98 (DRS)
Intervention Description
16 item clinician rated scale assessing delirium severity.
Intervention Type
Other
Intervention Name(s)
Telephone Interview for Cognitive Status - Modified (TICS-M)
Intervention Description
Telephone interview questionnaire evaluating patient cognitive status.
Intervention Type
Other
Intervention Name(s)
Opioid Equivalents measured by Morphine Milligram Equivalents (MME)
Intervention Description
The amount of opioids administered will be collected through patient self-report
Intervention Type
Other
Intervention Name(s)
Patient Health Questionnaire depression scale (PHQ-8)
Intervention Description
Questionnaire used to diagnose and determine the severity measure for depressive disorders.
Intervention Type
Other
Intervention Name(s)
Pain Catastrophizing
Intervention Description
Scale used to determine pain catastrophizing and it's severity.
Intervention Type
Other
Intervention Name(s)
Fear Avoidance Beliefs Questionnaire (FABQ)
Intervention Description
Questionnaire used to help predict patients that have a high pain avoidance behavior.
Intervention Type
Other
Intervention Name(s)
Opioid Side Effects and Likeability Questionnaire
Intervention Description
Survey determining adverse events related to opioid side effects and complications.
Intervention Type
Other
Intervention Name(s)
Daily Pain Trajectory
Intervention Description
Questionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate.
Intervention Type
Other
Intervention Name(s)
Tampa Scale of Kinesiophobia
Intervention Description
Questionnaire assessing Kinesiophobia
Intervention Type
Other
Intervention Name(s)
Quality of Recovery 15
Intervention Description
Questionnaire assessing postoperative quality of recovery
Primary Outcome Measure Information:
Title
Numerical Rating Score
Description
Change in pain will be assessed using the Numerical Rating Score Questionnaire immediately before surgery and at 2, 6 and 12 weeks post-operatively.
Time Frame
Change assessed from pre-surgery to 12 weeks post-operatively.
Title
Daily Pain Trajectory
Description
Change in pain will be assessed using the Daily Pain Trajectory survey each day post-operatively for 30 days.
Time Frame
Change assessed from 1 day to 30 days post-operatively
Title
Pain Catastrophizing
Description
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.
Time Frame
Change from Pre-operation score to 12 weeks post-operatively
Title
Pain Fear and Avoidance
Description
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.
Time Frame
Change from Pre-operation score to 12 weeks post-operatively
Title
Pain Interference
Description
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.
Time Frame
Change from Pre-operation score to 12 weeks post-operatively
Title
Generalized Anxiety Disorder
Description
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.
Time Frame
Change from pre-operation score to 12 weeks post-operatively
Title
Personal Health Questionnaire Depression Scale
Description
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.
Time Frame
Change from pre-operation score to 12 weeks post-operatively
Title
Oswestry disability index
Description
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.
Time Frame
Change from Pre-operative score to 12 weeks post-operatively
Title
Tampa Scale of Kinesiophobia
Description
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.
Time Frame
Change from Pre-operative score to 12 weeks post-operatively
Title
Delirium Rating Scale-Revised-98
Description
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.
Time Frame
Change from Pre-operative score to 12 weeks post-operatively
Title
3D-CAM-S and 3D-CAM-ICU
Description
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.
Time Frame
Change from Pre-operative score to 12 weeks post-operatively
Title
Modified Telephone Interview of Cognitive Status
Description
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.
Time Frame
Change from Pre-operative score to 12 weeks post-operatively
Title
Saint Louis University Mental Status Examination (SLUMs)
Description
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.
Time Frame
Change from Pre-operative score to 12 weeks post-operatively.
Secondary Outcome Measure Information:
Title
Opioid Use
Description
Opioid use will be calculated pre- and post-operatively using the Morphine Milligram Equivalents from patient self-reports.
Time Frame
Change from pre-operative score through 12 weeks post-operatively
Title
Opioid Side Effects and Likability Questionnaire
Description
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.
Time Frame
Change from 1 week post-operative results to 4 weeks post-operation.
Title
Self-reported Adverse Events
Description
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
Time Frame
Change from pre-operative result through 12 weeks post-operatively.
Title
Length of Hospitalization
Description
The length of time patients were hospitalized will be collected through the electronic health record.
Time Frame
Through study completion, 16 months
Title
Disposition to skilled-facilities
Description
Where patients are dispositioned post-operatively will be collected through the electronic health record.
Time Frame
Through study completion, 16 months
Title
90-day Readmission Rates
Description
The 90-day readmission rates will be collected through the electronic health record.
Time Frame
Through study completion, 16 months
Title
Blood test for Inflammation
Description
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.
Time Frame
Measured Immediately before surgery and 1 day post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alex R Coffman, BS
Phone
319-353-8996
Email
alex-coffman@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine R Olinger, MD
Phone
319-384-5892
Email
catherine-olinger@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine R Olinger, MD
Organizational Affiliation
Clinical Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion

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