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

Completed · Early Phase 1

Conditions studied: Lumbar Spinal Stenosis, Lumbar Spinal Instability, Lumbar Spine Degeneration

In brief

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.

Key facts

Study ID

NCT03088306

Run by

Johns Hopkins University

People needed

49

Starts

2017-07-01

Expected to finish

2018-08-31

Last updated by the study team

2018-10-16

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligible participants will be English-speaking adults who are presenting to a spine surgeon (orthopaedic or neurosurgeon) for surgical treatment of a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis (i.e. fusion).

You may not qualify if…

• A microsurgical technique as the primary procedure, such as an isolated laminotomy or microdiscectomy.
• Spinal deformity as the primary indication for surgery.
• Spine surgery secondary to pseudarthrosis, trauma, infection, or tumor.
• Back and/or lower extremity pain < 3 months indicating no history of sub-acute or chronic pain.
• History of neurological disorder or disease, resulting in moderate to severe movement dysfunction.
• Presence of schizophrenia or other psychotic disorder.
• Patient refusal to participate.
• Known allergic reactions to any of the study medications
• Surgery under a workman's compensation claim.
• Not able to return to clinic for standard follow-up visits with surgeon.
• Unable to provide a stable address and access to a telephone.

Where it is running

• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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