Actively Recruiting

Early Phase 1
Age: 65Years +
All Genders
ID05461092

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

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of thoracolumbar interfascial plane (TLIP) blocks in older adults undergoing spinal fusion surgery. This early phase study aims to test the feasibility of implementing TLIP blocks, which involve anesthesia applied to the back near the surgery site. The goal is to gather information on recruitment, assessment completion, dropout rates, patient feedback, and potential barriers to using TLIP blocks. This feasibility study will also help plan a larger randomized trial to assess the impact of TLIP blocks on pain, physical function, opioid use, and delirium in this population. Participants will be randomly assigned to one of two groups: one receiving standard anesthesia care without TLIP blocks, and the other receiving standard anesthesia plus a TLIP block with bupivacaine during surgery. The TLIP block is given after anesthesia but before spinal fusion. The study includes various questionnaires and assessments related to pain, anxiety, depression, disability, delirium, and cognitive function. Blood tests will measure inflammation markers before and after surgery. During the study, participants will complete multiple assessments from before surgery up to 12 weeks post-operation, including pain scores, mental health evaluations, and delirium severity ratings. Researchers will monitor opioid use, side effects, hospital stay length, readmission rates, and disposition to care facilities over 16 months. The study will also collect patient-reported adverse events and use several detailed questionnaires to measure recovery and function after surgery.

CONDITIONS

Brief 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 surgery of three or fewer levels
  • Undergoing elective surgery
  • Have no contraindications to local anesthetic or procedure
  • Do not have severe cardiac or respiratory disease
  • Do not have preexisting cognitive dysfunction or dementia
Not Eligible

You will not qualify if you...

  • Are 64 years old or younger
  • Require emergency treatment
  • Have pathologic fractures
  • Seeking revision surgery
  • Have major liver or kidney dysfunction
  • Have coexisting hematological disorder or irreversible abnormal coagulation
  • Have previous diagnosis of dementia or SLUMS score below 20
  • Are unable to communicate, cooperate, or have language barriers
  • Have body mass index over 40
  • Are allergic to study medications
  • Are opioid tolerant (oral morphine equivalent over 60 mg/day)
  • Have other chronic pain sources like fibromyalgia
  • Have significant CNS or respiratory disease requiring home oxygen
  • Are incarcerated
  • Have psychiatric illnesses or major preoperative neurological deficits
  • Are pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day plus hospital stay

Participants undergo lumbar spinal fusion surgery and receive either standard anesthesia alone or with an additional regional nerve block called the Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine during surgery.

1 surgical visit and hospital stay

Post-operative Follow-up

Duration - Up to 12 weeks post-operatively

Participants are monitored for pain, cognitive function, opioid use, and recovery through questionnaires and blood tests after surgery.

Weekly visits for up to 12 weeks

Long-term Monitoring

Duration - Up to 16 months post-operatively

Participants are observed for longer-term outcomes including hospitalization length, readmission, and disposition to skilled facilities.

Periodic follow-up contacts during 16 months

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

C

Catherine R Olinger, MD

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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Published Research Related To This Trial

Intra- versus postoperative initiation of pain control via a thoracic epidural catheter for lumbar spinal fusion surgery.

Manuel Wenk, Ulf Liljenqvist, Thomas Kaulingfrecks...

https://pubmed.ncbi.nlm.nih.gov/28984097

Evaluation of ultrasound-guided lateral thoracolumbar interfascial plane block for postoperative analgesia in lumbar spine fusion surgery: a prospective, randomized, and controlled clinical trial.

Ke Chen, Lizhen Wang, Meng Ning...

https://pubmed.ncbi.nlm.nih.gov/31681518

The Saskatchewan health and back pain survey. The prevalence of low back pain and related disability in Saskatchewan adults.

J D Cassidy, L J Carroll, P Côté

https://pubmed.ncbi.nlm.nih.gov/9762743

Patient-Reported Outcomes Measurement Information System physical function and pain interference in spine surgery.

Jawad M Khalifeh, Christopher F Dibble, Ammar H Hawasli...

https://pubmed.ncbi.nlm.nih.gov/31026819

Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial.

Ashish K Khanna, Sergio D Bergese, Carla R Jungquist...

https://pubmed.ncbi.nlm.nih.gov/32925318