Using nerve blocks to reduce pain and improve recovery in older adults after spinal surgery
Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion
This study is testing if a special nerve block can help older adults feel less pain and recover better after spinal surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT05461092 on ClinicalTrials.gov |
What this trial studies
This feasibility study investigates the use of thoracolumbar interfascial plane (TLIP) blocks in older adults undergoing spinal fusion surgery. The TLIP blocks involve administering anesthesia to the back to potentially reduce post-operative pain. The study will assess recruitment rates, completion of assessments, and patient feedback, while identifying barriers to implementing TLIP blocks. The findings will help refine methods and determine sample size for a future larger randomized clinical trial aimed at evaluating the effects of TLIP blocks on pain, physical function, opioid use, and delirium in this population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 and older who are scheduled for elective lumbar spinal fusion surgery.
Not a fit: Patients who are younger than 65, have severe cardiac or respiratory diseases, or preexisting cognitive dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-operative pain and improve recovery outcomes for older adults undergoing spinal fusion.
How similar studies have performed: Previous studies have shown that nerve blocks can effectively reduce post-operative pain, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Iowa City, Iowa
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Principal investigator: Catherine R Olinger, MD — Clinical Assistant Professor
- Study coordinator: Alex R Coffman, BS
- Email: alex-coffman@uiowa.edu
- Phone: 319-353-8996
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.