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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Iowa

About this trial

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

Qualifiers

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

Disqualifiers

64 years old and younger

emergency treatment

pathologic fractures

seeking revision surgery

Trial design

Treatments tested in this trial

  • Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
  • Blood Test
  • 3D CAM Delirium Severity Scoring
  • Generalized Anxiety Disorder 7-item (GAD-7) scale
  • Numerical Rating Score (NRS)
  • PROMIS-Pain Interference
  • Oswestry Disability Index (ODI)
  • Saint Louis University Mental Status Examination (SLUMs)
  • Delirium Rating Scale-Revised-98 (DRS)
  • Telephone Interview for Cognitive Status - Modified (TICS-M)
  • Opioid Equivalents measured by Morphine Milligram Equivalents (MME)
  • Patient Health Questionnaire depression scale (PHQ-8)
  • Pain Catastrophizing
  • Fear Avoidance Beliefs Questionnaire (FABQ)
  • Opioid Side Effects and Likeability Questionnaire
  • Daily Pain Trajectory
  • Tampa Scale of Kinesiophobia
  • Quality of Recovery 15

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators