NCT05461092 Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion
| NCT ID | NCT05461092 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Iowa |
| Condition | Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2024-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Catherine R Olinger, MD
PRINCIPAL INVESTIGATOR
Clinical Assistant Professor
Frequently Asked Questions
Who can join the NCT05461092 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05461092 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05461092 currently recruiting?
Yes, NCT05461092 is actively recruiting participants. Contact the research team at alex-coffman@uiowa.edu for enrollment information.
Where is the NCT05461092 trial being conducted?
This trial is being conducted at Iowa City, United States.
Who is sponsoring the NCT05461092 clinical trial?
NCT05461092 is sponsored by University of Iowa. The principal investigator is Catherine R Olinger, MD at Clinical Assistant Professor. The trial plans to enroll 50 participants.