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

Status: Recruiting
Location: See location...
Intervention Type: Other, Diagnostic test, Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Iowa
University of Iowa
RECRUITING
Iowa City
Contact Information
Primary
Alex R Coffman, BS
alex-coffman@uiowa.edu
319-353-8996
Backup
Catherine R Olinger, MD
catherine-olinger@uiowa.edu
319-384-5892
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 50
Treatments
Active_comparator: Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Experimental: Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Related Therapeutic Areas
Sponsors
Leads: University of Iowa

This content was sourced from clinicaltrials.gov