Post-operative Pain Clinical Trial
Official title:
Improving Patient Outcomes Using Multimodal Perioperative Pain Management: The ComfortSafe Program
Proposed is a demonstration project to characterize the immediate, short-term and long-term pain and other post-operative outcomes of 60, self-selected breast (n=20), caesarian-section (n=20) and abdominal (n=20) surgical patients who receive opioid-sparing, multimodal anesthesia and pain management care as guided by the ComfortSafe Pyramid.
In well-characterized samples of patients undergoing breast, caesarian-section or abdominal
surgery, the efficacy and safety of perioperative pain care organized by ComfortSafe Pyramid
approaches will be evaluated. In addition, patient satisfaction with this care will be
evaluated. Post-operative pain and opioid-related outcomes will be operationalized using
standardized symptom (nausea, vomiting, respiratory depression, confusion, acute and chronic
pain) severity measures, prn analgesic (opioid and non-opioid) consumption, and urine
toxicology. Together, these original data will have important implications for the clinical
management of post-operative pain utilizing opioid-sparing and multi-modal approaches.
A total of 60 self-selected surgical patients will be enrolled in the study, 20 undergoing
breast surgery, 20 undergoing caesarian-section, and 20 undergoing abdominal surgery. All
will receive anesthesia and pain management consistent with the ComfortSafe Pyramid which
emphasizes opioid-sparing and multimodal approaches. Side and adverse opioid-related effects
and post-operative pain will be assessed at regular intervals during the immediate
post-operative period (24 hours). To evaluate the incidence of opioid misuse/abuse and the
development of chronic pain, an opioid use history, urine toxicology and Brief Pain Inventory
will be collected at 1 month, 3 months and 6 months following discharge. Patient satisfaction
measures will be obtained at discharge, 1 month, and 3 months follow-up timepoint.
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