RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05461092

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Are 65 or older
  2. * Indicated for lumbar spinal fusion of less than or equal to 3 levels
  3. * Undergoing elective surgery
  4. * no contraindications to local anesthetic or procedures
  5. * no severe cardiac or respiratory disease
  6. * no preexisting cognitive dysfunction/dementia
  1. * 64 years old and younger
  2. * emergency treatment
  3. * pathologic fractures
  4. * seeking revision surgery
  5. * major liver or kidney dysfunction
  6. * coexisting hematological disorder or irreversible abnormal coagulation
  7. * patients with previous diagnosis of dementia or SLUMS score \<20
  8. * patient unable to communicate/cooperate/language barrier
  9. * BMI\>40
  10. * allergy to study medications
  11. * opioid tolerant (oral opioid intake morphine equivalent =\< 60 mg/day)
  12. * other sources of chronic pain like fibromyalgia
  13. * patients with associated significant CNS or respiratory disease (home oxygen requirements)
  14. * incarcerated patients
  15. * psychiatric illnesses preoperative neurological deficits greater than one motor group, less than three out of five motor functions
  16. * pregnant or breast feeding

Contacts and Locations

Study Contact

Alex R Coffman, BS
CONTACT
319-353-8996
alex-coffman@uiowa.edu
Catherine R Olinger, MD
CONTACT
319-384-5892
catherine-olinger@uiowa.edu

Principal Investigator

Catherine R Olinger, MD
PRINCIPAL_INVESTIGATOR
Clinical Assistant Professor

Study Locations (Sites)

University of Iowa
Iowa City, Iowa, 52242
United States

Collaborators and Investigators

Sponsor: University of Iowa

  • Catherine R Olinger, MD, PRINCIPAL_INVESTIGATOR, Clinical Assistant Professor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-01-01
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Delirium
  • Pain, Back
  • Spinal Fusion
  • Thoracolumbar Interfascial Plane Block