Effects of Erector Spinae Plane Block on Postoperative Pain Following Lumbar Fusion Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Erector Spinae Plane Block, Subcutaneous Anesthesia.
- Who it may be relevant to
- Registry conditions: Fusion of Spine, Lumbar Region, Anesthesia, Local, Pain, Postoperative, Opioid Use. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Opioid Usage and Patient Reported Outcome Comparison Following Erector Spinae Plane Block or Subcutaneous Anesthetic in Spinal Fusion Procedures
Overview
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.
Interventions
- Procedure 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. - 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.
Primary outcome measures
- MOS 36 Item Short Form Health Status Survey (SF-36) [Time frame: 3 months]
- Oswestry Disability Index [Time frame: 3 months]
- Postoperative Opioid Usage [Time frame: 2 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UMass Chan Medical School/UMass Memorial Medical Center — Worcester
Identifiers
NCT: NCT06528288 · STUDY00001297