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NCT Number: NCT06528288

Effects of Erector Spinae Plane Block on Postoperative Pain Following Lumbar Fusion Surgery

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.

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Key information

Conditions

Fusion of Spine, Lumbar Region Anesthesia, Local Neurologic Manifestations Opioid Use Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Chan Medical School/UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location status: Recruiting

Location contact

Michael Stauff, MD

CONTACT

[email protected]

Michael Stauff, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erector Spinae Plane Block

Procedure

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

Procedure

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 outcomes

  1. MOS 36 Item Short Form Health Status Survey (SF-36)

    Time frame: 3 months

    Questionnaire related to a patient's general health, bodily pain, physical function, and mental health. Scoring includes eight scaled scores, which are the weighted sums of the questions in their section. Scales are converted into a 0-100 scale. The lower the score the more disability. The higher the score the more functionality and therefore indicating better outcome.

  2. Oswestry Disability Index

    Time frame: 3 months

    Questionnaire related to a patient's back pain and its impact on their day-to-day activities. There are 10 questions, each weighted from 0-5 points. The point total of each question is added together to give a final scaled score ranging from 0-50. Lower scores near 0 are indicative of better outcome and less disability, while higher scores near 50 indicate worse outcomes and more disability.

  3. Postoperative Opioid Usage

    Time frame: 2 weeks

    This is a tracking sheet for the amount of opioid medications used in the first 2 weeks of postoperative recovery.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael P Stauff, MD

CONTACT

[email protected]

508-334-9764

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

Opioid Usage and Patient Reported Outcome Comparison Following Erector Spinae Plane Block or Subcutaneous Anesthetic in Spinal Fusion Procedures

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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