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

NCT ID: NCT06528288

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-13
• Study Completion Date: 2026-07-01

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Subcutaneous Anesthesia

Intervention Type: 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.

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Michael Stauff

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Stauff, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Chan Medical School

Locations

UMass Chan Medical School/UMass Memorial Medical Center

Worcester, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael P Stauff, MD

Role: CONTACT

Michael.Stauff@umassmed.edu

508-334-9764

Facility Contacts

Michael Stauff, MD

Role: primary

Michael.Stauff@umassmed.edu

Other Identifiers

STUDY00001297

Identifier Type: -

Identifier Source: org_study_id