drugset / Trial / NCT03088306

Improving Pain and Reducing Opioid Use (IPaRO) in Lumbar Spine Surgery Patients

NCT03088306 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

Patients presenting for lumbar spine surgery experience pain related to their spine condition. Following surgery, these patients also experience surgical pain resulting from disruption of skin, muscle tissue, vertebrae, intervertebral discs, and facet joints. This pain is often treated with opioid medications - with roughly 40% of patient experiencing sub-optimal pain management. Adequate pain control has become a top priority among professional societies, healthcare systems, and accrediting agencies. The current proposal will provide this critical evidence of feasibility and acceptability of a multi-modal pain management plan for patients undergoing lumbar spine surgery. Additionally, this study will provide critical preliminary data to compare the effectiveness of protocol-driven multi-modal pain management to control post-operative pain, reduce opioid medication use, and improve physical activity, sleep, and health.

Timeline

Start
2017-07-01
Primary completion
2018-05-31
Completion
2018-08-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 1 g Oral
Comparator Diazepam Small molecule — —
Comparator Fentanyl Other / unclassified — —
Comparator Gabapentin Unknown 600 mg Oral
Comparator Gabapentin Unknown 1200 mg Oral
Comparator Hydromorphone Other / unclassified — —
Comparator Ketamine Small molecule 10 ug/kg Intravenous