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

University of Massachusetts, Worcester

Status: Enrolling

Conditions: Fusion of Spine, Lumbar Region; Anesthesia, Local; Pain, Postoperative; Opioid Use

Treatments: Procedure: Subcutaneous Anesthesia; Procedure: Erector Spinae Plane Block

Study type: Interventional

Funder types: Other

Identifiers

NCT06528288

STUDY00001297

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

Erector Spinae Plane Block

Experimental group

Description:

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.

Treatment:

Procedure: Erector Spinae Plane Block

Subcutaneous Anesthesia

Active Comparator group

Description:

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.

Treatment:

Procedure: Subcutaneous Anesthesia