Lumbar Spinal Stenosis Clinical Trial
Official title:
Comparative Effectiveness of Multi-modal Pain Management Versus Standard Intra- and Post-operative Analgesia: Randomized Controlled Clinical Trial to Reduce Post-operative Pain and Opioid Use Among Patients Undergoing Lumbar Spine Surgery
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.
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. Proper
pain management is necessary to reduce pain-related and medication side effects and to
promote rehabilitation. 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.
Multi-modal pain management strategies have been proposed to (1) control pre-operative pain
related to spine pathology; (2) employ non-opioid medication peri-operatively to pre-empt
post-operative surgical pain; and (3) monitor and control pain intensity before and after
surgery. There is a demonstrated lack of evidence regarding optimal post-operative protocols
and pathways. The investigators have planned a randomized clinical trial to compare the
effectiveness of two methods of peri-operative pain management to reduce post-operative pain
and opioid use among patients undergoing lumbar spine surgery.
Prior to submission to National Institutes of Health (NIH), Agency for Healthcare Research
and Quality (AHRQ), or Patient Centered Outcomes Research Institute (PCORI), it is necessary
to demonstrate the feasibility and acceptability of the trial protocol. 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.
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