RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-13
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06528288

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The individual has signed and dated a study specific informed consent form approved by the Institutional Review Board at UMMHC.
  2. * The individual is at least 18 years of age.
  3. * The individual is skeletally mature (over the age of 18).
  4. * The patient is scheduled for a one or two level lumbar spinal fusion.
  1. * Patients unable to consent for themselves.
  2. * Pregnant women.
  3. * Non-English speaking subjects.
  4. * Prisoners.
  5. * Spinal fusion procedures for a diagnosis of fracture, tumor, and/or infection.
  6. * Patients who have used opioids for more than 10 days in the month prior to their operation.
  7. * Patients with a body mass index (BMI) of 35 or greater.

Contacts and Locations

Study Contact

Raj J Gala, MD
CONTACT
773-600-1927
Raj.Gala@umassmed.edu
Michael P Stauff, MD
CONTACT
508-334-9764
Michael.Stauff@umassmemorial.org

Principal Investigator

Raj J Gala, MD
PRINCIPAL_INVESTIGATOR
UMass Chan Medical School, Assistant Professor

Study Locations (Sites)

UMass Chan Medical School/UMass Memorial Medical Center
Worcester, Massachusetts, 01655
United States

Collaborators and Investigators

Sponsor: Raj Gala

  • Raj J Gala, MD, PRINCIPAL_INVESTIGATOR, UMass Chan Medical School, Assistant Professor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-13
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2024-09-13
Study Completion Date2025-07-01

Terms related to this study

Keywords Provided by Researchers

  • Erector Spinae Plane Block
  • Spinal Fusion
  • Patient Reported Outcomes
  • Opioid Usage

Additional Relevant MeSH Terms

  • Fusion of Spine, Lumbar Region
  • Anesthesia, Local
  • Pain, Postoperative
  • Opioid Use