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

Not Applicable

Recruiting

• Conditions: Opioid Use; Fusion of Spine, Lumbar Region; Anesthesia, Local; Pain, Postoperative
• Interventions: Procedure: Erector Spinae Plane Block; Procedure: Subcutaneous Anesthesia

• Registration Number: NCT06528288
• Lead Sponsor: University of Massachusetts, Worcester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-30
• Study Start: 2024-09-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-01-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector Spinae Plane Block	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.
Subcutaneous Anesthesia	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Opioid Usage	2 weeks	This is a tracking sheet for the amount of opioid medications used in the first 2 weeks of postoperative recovery.
MOS 36 Item Short Form Health Status Survey (SF-36)	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.
Oswestry Disability Index	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.

Trial Locations

Locations (1)

UMass Chan Medical School/UMass Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States