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Thoracolumbar Block for Spinal Fusion Recovery

Phase < 1

Recruiting

Led By Catherine R Olinger, MD

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing elective surgery

Indicated for lumbar spinal fusion of less than or equal to 3 levels

Must not have

Opioid tolerant (oral opioid intake morphine equivalent =< 60 mg/day)

Age 64 years old and younger

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, 16 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a pain-relieving block can help older adults who are having spinal surgery.

Who is the study for?

This trial is for adults aged 65 or older who need lumbar spinal fusion surgery of up to three levels and have no severe heart, lung diseases, cognitive dysfunction, or allergies to local anesthetics. It's not for those with major liver/kidney issues, opioid tolerance, other chronic pain conditions, significant neurological deficits, psychiatric illnesses, under age 65, pregnant/breastfeeding women or those with a high BMI.

What is being tested?

The study tests the effectiveness of TLIP blocks using bupivacaine anesthesia in reducing post-operative pain and improving recovery in older adults after spinal fusion. It aims to assess feasibility for a larger trial by looking at recruitment rates and patient feedback on this pain management technique.

What are the potential side effects?

Potential side effects from the TLIP block may include localized numbness or weakness due to the anesthesia (bupivacaine), allergic reactions to medication used during the procedure and possible discomfort at injection sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a planned surgery.

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I am recommended to have a spinal fusion surgery for up to 3 spine levels.

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I do not have serious heart or lung conditions.

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I am 65 years old or older.

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I am not allergic to local anesthetics.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I take less than or equal to 60 mg/day of opioids.

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I am 64 years old or younger.

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I require immediate medical attention.

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I have had a fracture caused by a medical condition.

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I am looking to have a corrective surgery.

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I have a psychiatric illness or a significant loss in my ability to move.

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I have a blood disorder or a permanent clotting issue.

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I require home oxygen or have significant brain or lung disease.

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I have significant liver or kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, 16 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, 16 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, 16 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

3D-CAM-S and 3D-CAM-ICU

Daily Pain Trajectory

Delirium Rating Scale-Revised-98

+10 more

Secondary study objectives

90-day Readmission Rates

Blood test for Inflammation

Disposition to skilled-facilities

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaineExperimental Treatment18 Interventions

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

Group II: Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.Active Control17 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blood Test

2021

N/A

~360

0 / 14Eligibility criteria met