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

Johns Hopkins University

Status and phase: Completed; Early Phase 1

Conditions: Lumbar Spine Degeneration; Lumbar Spinal Stenosis; Lumbar Spinal Instability

Treatments: Drug: Multi-modal pain management [Fentanyl]; Drug: Multi-modal pain management [Valium + Gabapentin]; Drug: Multi-modal pain management [Acetaminophen + Gabapentin]; Drug: Multi-modal pain management [Intravenous Ketamine]; Drug: Standard analgesia use [Fentanyl]; Drug: Standard analgesia use [Volatile Anesthesia]; Drug: Standard analgesia use [Oxygen]; Drug: Standard analgesia use [Hydromorphone]

Study type: Interventional

Funder types: Other

Identifiers

NCT03088306

IRB00113816

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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49 participants in 2 patient groups

Standard analgesia use

Active Comparator group

Description:

A strategy to manage pain in the peri-operative period that is in common clinical use.

Treatment:

Drug: Standard analgesia use [Volatile Anesthesia]

Drug: Standard analgesia use [Hydromorphone]

Drug: Standard analgesia use [Fentanyl]

Drug: Standard analgesia use [Oxygen]

Multi-modal pain management

Active Comparator group

Description:

A strategy to manage pain in the peri-operative period that is in common clinical use that is designed to reduce the need for post-operative opioid medication.

Treatment:

Drug: Multi-modal pain management [Valium + Gabapentin]

Drug: Multi-modal pain management [Acetaminophen + Gabapentin]

Drug: Multi-modal pain management [Fentanyl]

Drug: Multi-modal pain management [Intravenous Ketamine]