Recruiting

ESPB vs. Subcutaneous

Sponsor:

University of Massachusetts, Worcester

Code:

NCT06528288

Conditions

Fusion of Spine, Lumbar Region

Anesthesia, Local

Pain, Postoperative

Opioid Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Erector Spinae Plane Block

Subcutaneous Anesthesia

Study Details

Brief summary:

The purpose of this study is to determine if the method for injecting local anesthesia affects patients' pain and opioid usage after surgery. The investigators will compare subcutaneous anesthesia, injections of anesthesia under the skin, to a method called erector spinae plane block (ESPB). An ESPB injection involves placing local anesthesia along the muscles and bones in the back, using a special type of x-ray called fluoroscopy for guidance. The Investigators will use patient reported outcomes (PROs) and track subjects' opioid usage to find out if there is a difference between ESPB and subcutaneous anesthesia. The investigators hypothesize that patients who get ESPB injections will use less opioids and report less pain after lumbar fusion surgery compared to patients who receive subcutaneous anesthesia injections.

Conditions

Fusion of Spine, Lumbar Region

Anesthesia, Local

Pain, Postoperative

Opioid Use

Study ID

NCT06528288

Start date

Sep 13, 2024

Status verified date

Mar, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • The individual has signed and dated a study specific informed consent form approved by the Institutional Review Board at UMMHC.
  • The individual is at least 18 years of age.
  • The individual is skeletally mature (over the age of 18).
  • The patient is scheduled for a one or two level lumbar spinal fusion.

Exclusion Criteria:

  • Patients unable to consent for themselves.
  • Pregnant women.
  • Non-English speaking subjects.
  • Prisoners.
  • Spinal fusion procedures for a diagnosis of fracture, tumor, and/or infection.
  • Patients who have used greater than 150 morphine milligram equivalents of opioids in the month prior to their operation.
  • Patients with a body mass index (BMI) of 40 or greater.

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Erector Spinae Plane Block

An erector spinae plane block (ESPB) will be administered prior to the surgical procedure, but after the patient receives general anesthesia. The injection will consist of 10 mL of saline, 20 mL of liposomal bupivacaine, and 30 mL of bupivacaine. This will be injected along the erector spinae fascial plane at the surgical levels. Fluoroscopy will be used for guidance during the injection.

active comparator: Subcutaneous Anesthesia

A subcutaneous anesthesia injection will be administered after the surgery has been completed, but while the patient is under general anesthesia. The injection will consist of 10 mL of saline, 20 mL of liposomal bupivacaine, and 30 mL of bupivacaine. This will be injected around the surgical incision, subcutaneously.

Interventions

Erector Spinae Plane Block

The erector spinae plane block (ESPB) is a method for injecting local anesthesia to reduce pain related to a surgical procedure. The anesthesia is theorized to spread along the paraspinal fascia and anesthetize a larger area, resulting in patients reporting less pain and using less opioids postoperatively.

Subcutaneous Anesthesia

Subcutaneous anesthesia injection involves placement of local anesthesia under the skin around the surgical incision. This is thought to reduce pain from the incision site postoperatively.

Primary outcome measure

  • MOS 36 Item Short Form Health Status Survey (SF-36) [ Time Frame: 3 months ]
  • Oswestry Disability Index [ Time Frame: 3 months ]
  • Postoperative Opioid Usage [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Michael P Stauff, MD

508-334-9764Michael.Stauff@umassmed.edu

Locations

UMass Chan Medical School/UMass Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Michael Stauff, MD

Michael.Stauff@umassmed.edu

Principal Investigator:

Michael Stauff, MD

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • Erector Spinae Plane Block
  • Spinal Fusion
  • Patient Reported Outcomes
  • Opioid Usage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-03-16.