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Taking people in United StatesEarly phase 1

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

Key facts

Who runs it
University of Iowa
Where
Iowa City, United StatesSee the site
Trial code
Status
Recruiting
Phase
Early phase 1
People taking part
50 people, planned
Started
1 Jan 2024
Expected to end
31 Dec 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • 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
Record updated
27 March 2026

Who can take part

Age
65 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • seeking revision surgery
  • patients with previous diagnosis of dementia or SLUMS score <20
  • coexisting hematological disorder or irreversible abnormal coagulation
  • allergy to study medications
  • patients with associated significant CNS or respiratory disease (home oxygen requirements)
  • psychiatric illnesses preoperative neurological deficits greater than one motor group, less than three out of five motor functions
  • 64 years old and younger
  • emergency treatment
  • pathologic fractures
  • major liver or kidney dysfunction
  • patient unable to communicate/cooperate/language barrier
  • BMI>40
  • opioid tolerant (oral opioid intake morphine equivalent =< 60 mg/day)
  • other sources of chronic pain like fibromyalgia
  • incarcerated patients
  • pregnant or breast feeding

Where in United States

  • University of IowaIowa City, United StatesContact: Alex R Coffman, BSTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.Existing treatment, for comparison

    Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.

    Treatment: 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, and Quality of Recovery 15

  • Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaineTreatment being tested

    Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.

    Treatment: 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, and Quality of Recovery 15

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
27 March 2026