Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion
Recruiting now · Early Phase 1
Conditions studied: Delirium, Pain, Back, Spinal Fusion, Thoracolumbar Interfascial Plane Block
In brief
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.
Key facts
- Study ID
- NCT05461092
- Run by
- University of Iowa
- People needed
- 50
- Starts
- 2024-01-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-27
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Iowa — Iowa City, Iowa, United States (enrolling)
Full record on ClinicalTrials.gov
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