Clinical trial NCT05461092: 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
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Delirium
Pain, Back
Spinal Fusion
Thoracolumbar Interfascial Plane Block
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Numerical Rating Score
timeFrame: Change assessed from pre-surgery to 12 weeks post-operatively.
measure: Daily Pain Trajectory
timeFrame: Change assessed from 1 day to 30 days post-operatively
measure: Pain Catastrophizing
timeFrame: Change from Pre-operation score to 12 weeks post-operatively
measure: Pain Fear and Avoidance
timeFrame: Change from Pre-operation score to 12 weeks post-operatively
measure: Pain Interference
timeFrame: Change from Pre-operation score to 12 weeks post-operatively
measure: Generalized Anxiety Disorder
timeFrame: Change from pre-operation score to 12 weeks post-operatively
measure: Personal Health Questionnaire Depression Scale
timeFrame: Change from pre-operation score to 12 weeks post-operatively
measure: Oswestry disability index
timeFrame: Change from Pre-operative score to 12 weeks post-operatively
measure: Tampa Scale of Kinesiophobia
timeFrame: Change from Pre-operative score to 12 weeks post-operatively
measure: Delirium Rating Scale-Revised-98
timeFrame: Change from Pre-operative score to 12 weeks post-operatively
measure: 3D-CAM-S and 3D-CAM-ICU
timeFrame: Change from Pre-operative score to 12 weeks post-operatively
measure: Modified Telephone Interview of Cognitive Status
timeFrame: Change from Pre-operative score to 12 weeks post-operatively
measure: Saint Louis University Mental Status Examination (SLUMs)
timeFrame: Change from Pre-operative score to 12 weeks post-operatively.
Secondary outcomes:
measure: Opioid Use
timeFrame: Change from pre-operative score through 12 weeks post-operatively
measure: Opioid Side Effects and Likability Questionnaire
timeFrame: Change from 1 week post-operative results to 4 weeks post-operation.
measure: Self-reported Adverse Events
timeFrame: Change from pre-operative result through 12 weeks post-operatively.
measure: Length of Hospitalization
timeFrame: Through study completion, 16 months
measure: Disposition to skilled-facilities
timeFrame: Through study completion, 16 months
measure: 90-day Readmission Rates
timeFrame: Through study completion, 16 months
measure: Blood test for Inflammation
timeFrame: Measured Immediately before surgery and 1 day post-operatively
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: Clinical Assistant Professor
name: Catherine R Olinger, MD
role: PRINCIPAL_INVESTIGATOR
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