Erector Spinae Plane Block vs Local Infiltration Following Fusion Surgery

February 10, 2026 updated by: Rashmi Mueller

A Randomized Controlled Trial Comparing the Effect of Erector Spinae Plane Blocks Versus High Volume Local Infiltration Analgesia on Pain, Inflammation and Cognitive Outcomes Following Thoraco-Lumbar Fusion Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Treatment arms include:

  • Group ESP (Erector Spinae Plane). This group receives general anesthesia with ESP (Erector Spinae Block) regional pain block prior to incision.
  • Group LIA (Local Infiltration Anesthesia). This group receives general anesthesia and surgical procedure will take place as planned. Prior to being awakened, the area of procedure will be infiltrated using local anesthetic (LIA).
  • Group GA. This group receives general anesthesia (GA) only and surgical procedure will follow standard conditions.

Pre-procedure activities for all groups will include survey evaluations. If the surveys demonstrate pre-procedure cognitive deficits, the subject's participation will cease.

All subjects who do not display deficits will complete baseline evaluations that include social history, pain medication history and rate their pain (scored from 1 to 10). The subjects will be randomized to a treatment group. Once the subject is asleep and prior to incision, laboratory blood tests will be drawn and again approximately 24 hours after the subject is received into the recovery unit. Following their surgical procedure, pain control for all subjects will be at the discretion of their primary care team. However, as part of the study, the amount of opioid medications required to control their pain and their pain rating score for the first 72 hours post surgery will be collected from the subject's medical record unless discharged from the hospital before this cutoff time. On post-operative days when subject remains in the hospital facility, repeat survey evaluations will be carried out and during the first 7 days of the subject's hospital stay and unanticipated event will be recorded from the subject's medical record.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Health Care Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for all groups:

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

Exclusion Criteria for all groups:

  1. Emergency surgery
  2. Allergy to study medications
  3. BMI less than 20 or greater than 50
  4. Major liver or kidney dysfunction or other pre-existing major organ dysfunction
  5. Revision surgery
  6. Opioid tolerant (60 mg morphine equivalents/day for 1 week) or narcotic dependence (opioid intake morphine equivalent greater than10 mg/day for more than 3 months)
  7. Other sources of chronic pain (e.g. fibromyalgia)
  8. Patients with associated significant central nervous system (CNS) or respiratory disease (home oxygen use)
  9. Pre-operative neurological deficits
  10. Co-existing hematological disorders or deranged coagulation parameters
  11. Significant psychiatric illnesses that impedes the subject's ability to provide informed consent
  12. Language barrier
  13. Vulnerable population (e.g. prisoners)
  14. Pregnant females
  15. History of recent myocardial infarction
  16. History of recent cardiac stent procedure (within 3 months)
  17. Cardiac ejection fraction < 30%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group GA: General anesthesia only
This group receives general anesthesia only and surgical procedure will follow standard conditions.
Active Comparator: Group ESP: Erector Spinae Block
This group receives general anesthesia with regional pain block (Erector Spinae Block) prior to incision.
Procedure: Erector Spinae Block
General anesthesia with Erector Spinae Plane Block
Active Comparator: Group LIA: Local Infiltration
This group receives general anesthesia and surgical procedure will take place as planned. Prior to being awakened, the area of procedure will be infiltrated.
Procedure: Local infiltration with local anesthetic
General anesthesia with local infiltration of local anesthetic:

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Quality of Recovery (QoR-15) Scores Between Treatment Groups
Time Frame: Change from pre-operation score to 1 day after surgery date
The Quality of Recovery-15 (QoR-15) is a patient reported assessment aimed to validate the patients recovery following surgical intervention. The subject is asked to provide a quantitative number to a series of questions. The answers are rated on a scale from 0 to 10, where 0 = none of the time and 10 = all of the time. The scores for all of the questions are summed and comparison between the treatment groups will be assessed.
Change from pre-operation score to 1 day after surgery date
Quantitate the Change in Delirium Symptoms; Pre- to post-operative day 1
Time Frame: Change from pre-operation score to 1 day after surgery date

Potential new onset of delirium following surgical procedure will be assessed using the standardized 3D CAM ASSESSMENT (3-Minute Diagnostic Interview for the Confusion Assessment Method (CAM)). The subject is asked a series of questions and their responses are recorded. This structured mental status assessment is designed to detect the presence or absence of delirium. "The CAM algorithm is considered positive if the following features are present: Feature 1) Acute onset or fluctuating course and Feature 2) Inattention and either Feature 3) Disorganized thinking or Feature 4) Altered level of consciousness."

Comparison between the treatment groups will be assessed and the presence of post-operative delirium reported.

Reference: Marcantonio et al., (PMID: 25329203) and training manual.
Change from pre-operation score to 1 day after surgery date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitate the Change in Delirium Symptoms; Pre- to post-operative day 3
Time Frame: Change from pre-operation score to 3 days after surgery date

Potential new onset of delirium following surgical procedure will be assessed using the standardized 3D CAM ASSESSMENT (3-Minute Diagnostic Interview for the Confusion Assessment Method (CAM)). The subject is asked a series of questions and their responses are recorded. This structured mental status assessment is designed to detect the presence or absence of delirium. "The CAM algorithm is considered positive if the following features are present: Feature 1) Acute onset or fluctuating course and Feature 2) Inattention and either Feature 3) Disorganized thinking or Feature 4) Altered level of consciousness."

Comparison between the treatment groups will be assessed and the presence of post-operative delirium reported.

Reference: Marcantonio et al., (PMID: 25329203) and training manual.
Change from pre-operation score to 3 days after surgery date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rashmi Mueller

Investigators

  • Principal Investigator: Rashmi Mueller, MD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2024

Primary Completion (Actual)

April 29, 2025

Study Completion (Actual)

April 29, 2025

Study Registration Dates

First Submitted

December 28, 2023

First Submitted That Met QC Criteria

December 28, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202201643

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.

IPD Sharing Time Frame

Individual participant data (IPD) will be available for sharing immediately after publication and ending 5 years following article publication.

IPD Sharing Access Criteria

Individual participant data (IPD) will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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