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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)
Masking Description
Participants will be masked to the treatment arm. The research team (outcomes assessors) involved in evaluation of subjects will be blinded to the treatment arm.

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Procedure: 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.
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.
  • Procedure: 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.

Recruiting Locations

UMass Chan Medical School/UMass Memorial Medical Center
Worcester, Massachusetts 01655
Contact:
Michael Stauff, MD
Michael.Stauff@umassmed.edu

More Details

Status
Recruiting
Sponsor
University of Massachusetts, Worcester

Study Contact

Michael P Stauff, MD
508-334-9764
Michael.Stauff@umassmed.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.