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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
UMass Chan Medical School/UMass Memorial Medical Center
RECRUITING
Worcester
Contact Information
Primary
Michael P Stauff, MD
Michael.Stauff@umassmed.edu
508-334-9764
Time Frame
Start Date: 2024-09-13
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 66
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: University of Massachusetts, Worcester

This content was sourced from clinicaltrials.gov