Actively Recruiting

Early Phase 1
Age: 65Years +
All Genders
NCT05461092

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

Led by University of Iowa · Updated on 2026-03-27

50

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Are 65 or older
  • Scheduled for lumbar spinal fusion of 3 levels or fewer
  • Undergoing elective surgery
  • No contraindications to local anesthetics or procedures
  • No severe cardiac or respiratory disease
  • No preexisting cognitive dysfunction or dementia
Not Eligible

You will not qualify if you...

  • Age 64 or younger
  • Emergency treatment
  • Pathologic fractures
  • Seeking revision surgery
  • Major liver or kidney dysfunction
  • Hematological disorder or irreversible abnormal coagulation
  • Previous diagnosis of dementia or SLUMS score below 20
  • Unable to communicate, cooperate, or language barrier
  • Body mass index over 40
  • Allergy to study medications
  • Opioid tolerance with morphine equivalent 60 mg/day or higher
  • Other chronic pain conditions like fibromyalgia
  • Significant central nervous system or respiratory disease requiring home oxygen
  • Incarcerated patients
  • Psychiatric illnesses
  • Preoperative neurological deficits affecting more than one motor group
  • Pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

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Research Team

A

Alex R Coffman, BS

CONTACT

C

Catherine R Olinger, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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