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

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.

Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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.