Clinical trial NCT03088306: Improving Pain and Reducing Opioid Use (IPaRO) in Lumbar Spine Surgery Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Lumbar Spinal Stenosis
Lumbar Spinal Instability
Lumbar Spine Degeneration
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: North American Spine Society
First posted: 2017-03-23
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants undergoing lumbar spine surgery with complete follow-up
timeFrame: 52 week
Secondary outcomes:
measure: Patient controlled analgesia (PCA) pump use
timeFrame: during surgical hospitalization, up to 12 weeks
measure: Opioid medication use
timeFrame: up to 90 days
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pain
timeFrame: at 6 and 12 weeks
measure: PROMIS Physical Function
timeFrame: at 6 and 12 weeks
measure: PROMIS Fatigue
timeFrame: at 6 and 12 weeks
measure: PROMIS Anxiety
timeFrame: at 6 and 12 weeks
measure: PROMIS Depression
timeFrame: at 6 and 12 weeks
measure: PROMIS Sleep Disturbance
timeFrame: at 6 and 12 weeks
measure: PROMIS Satisfaction with Social Roles
timeFrame: at 6 and 12 weeks
measure: Health status (Medical Outcome Study Short Form 12, version 2)
timeFrame: at 6 and 12 weeks
measure: Oswestry Disability Index (ODI)
timeFrame: at 6 and 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Richard L Skolasky, ScD
role: PRINCIPAL_INVESTIGATOR
References: