Study of Opioid Use After Lumbar and Cervical Spine Surgery (SOULCS)
Status
Conditions
Treatments
Details and patient eligibility
About
The purpose of this project is to assess the impact of an educational video on the use of prescription opioid medication during a 6-month period following spine surgery. Subjects will be recruited from the pool of patients coming in for the pre-operative appointment prior to spine surgery. Patients that consent and enroll will be randomized to receive either a brief educational video at this appointment or usual care. Patients will be followed after surgery weekly for the first month, and then again at 6 months to determine their prescription opioid medication utilization patterns. Prescription data will also be pulled from electronic medical records.
Full description
After consenting, meeting inclusion criteria, and enrollment, all participants will complete several standard self-report questionnaires related to medical history, social demographic, and psychosocial variables that are related to low back pain, and often used in clinics that manage patients with low back pain. They will then be randomized to either receive the education, or only usual care (which is the typical information the surgeon provides the patient verbally during the pre-operative appointment). All patients will receive the usual care education from their surgeon.
Education Group:
The educational video is a white board style patient-centric video. The content of the education focus on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer on-acute pain. It also discusses some of the dangers of long-term opioid usage.
All Subjects:
All subjects will receive the usual care education that is typically given by their surgeon. That will be left up to the discretion of each surgeon.
All patients will proceed with the surgical procedure as planned. Each week during the 1-month period after the surgery, patients will be contacted, and then again at 6 months to ask history of prescription opioid utilization.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Currently scheduled for a pre-operative appointment with an orthopaedic spine surgeon or neurosurgeon specifically for a lumbar surgery.
- Surgery is taking place for a condition that has been ongoing for 6 months or longer (chronic)
- Between the age of 18 - 65 years
- Read and speak English well enough to understand the education, provide informed consent and follow study instructions
Exclusion criteria
a. Known aversion or allergy that would prevent the patient from taking any opioid based pain medication
Trial design
Primary purpose
Allocation
Interventional model
Masking
120 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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