Anesthesia, Local, Fusion of Spine, Lumbar Region, Opioid Use, Pain, Postoperative
Conditions
Keywords
Erector Spinae Plane Block, Spinal Fusion, Patient Reported Outcomes, Opioid Usage
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.
Interventions
PROCEDUREErector 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.
PROCEDURESubcutaneous 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.
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be masked to the treatment arm. The research team (outcomes assessors) involved in evaluation of subjects will be blinded to the treatment arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Contacts
CONTACTMichael P Stauff, MD
PRINCIPAL_INVESTIGATORMichael Stauff, MD
UMass Chan Medical School
Outcome results
None listed