Effects of Erector Spinae Plane Block on Postoperative Pain Following Lumbar Fusion Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Massachusetts, Worcester
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients unable to consent for themselves.
Pregnant women.
Non-English speaking subjects.
Prisoners.
Trial design
Design model
Parallel
Treatments tested in this trial
Erector Spinae Plane Block
Procedure/SurgeryThe 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
Procedure/SurgerySubcutaneous 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Erector Spinae Plane BlockExperimental treatment 1 intervention
Group B: Subcutaneous AnesthesiaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
MOS 36 Item Short Form Health Status Survey (SF-36)
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.
Time frame
3 months2
Oswestry Disability Index
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.
Time frame
3 months3
Postoperative Opioid Usage
This is a tracking sheet for the amount of opioid medications used in the first 2 weeks of postoperative recovery.
Time frame
2 weeksSponsors and contacts
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Source ClinicalTrials.gov