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

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Lumbar Spinal Instability
• Lumbar Spinal Stenosis
• Lumbar Spine Degeneration
• Spinal Stenosis
• Spondylarthritis

• NCT number: NCT03088306
• Study type: Interventional
• Source: Johns Hopkins University
• Status: Completed
• Phase: Early Phase 1
• Start date: July 1, 2017
• Completion date: August 31, 2018