CompletedPhase 2

Erector Spinae Plane Block vs Local Infiltration Following Fusion Surgery

United States29 participantsStarted 2024-05-15

Plain-language summary

The proposed intervention will examine two alternative methods for postoperative pain control. Two treatment arms of this study will include subjects who receive an erector spinae block (ESP) after induction of anesthesia but prior to the start of surgery and subjects who will receive a high volume of local anesthetic infiltration at the end of the procedure before emergence from anesthesia. The control group of subjects will undergo spinal surgery with general anesthesia but without any regional anesthesia. Outcome measurements include evaluation of serum inflammatory markers, pain scores, opioid usage and standardized evidence-based assessment methodologies.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age: Greater than 18 years but less than 80
. Surgical procedure: 1 to 2 level thoraco-lumbar fusion between T8 and S2; non-emergent surgery
. Opioid naive (less than 6 oxycodone/day or 30 mg oxycodone equivalent)
. No contraindication to local anesthetics or regional procedures.

Exclusion criteria

. Emergency surgery
. Allergy to study medications
. BMI less than 20 or greater than 50

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comparison of Quality of Recovery (QoR-15) Scores Between Treatment Groups

Timeframe: Change from pre-operation score to 1 day after surgery date

Quantitate the Change in Delirium Symptoms; Pre- to post-operative day 1

Timeframe: Change from pre-operation score to 1 day after surgery date

Trial details

NCT IDNCT06199999

SponsorRashmi Mueller

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-29

View on ClinicalTrials.gov More Postoperative Delirium trials