Improving Pain and Reducing Opioid Use (IPaRO) in Lumbar Spine Surgery Patients
Condition: Lumbar Spinal Stenosis; Lumbar Spinal Instability; Lumbar Spine Degeneration
MeSH terms: Spinal Stenosis
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): Standard analgesia use [Oxygen]; Standard analgesia use [Hydromorphone]; Standard analgesia use [Volatile Anesthesia]; Standard analgesia use [Fentanyl]; Multi-modal pain management [Acetaminophen + Gabapentin]; Multi-modal pain management [Fentanyl]; Multi-modal pain management [Intravenous Ketamine]; Multi-modal pain management [Valium + Gabapentin]
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.; A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.; A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.; A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.; Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge.; Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge.; Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge.; Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge.
Intervention MeSH terms: Acetaminophen; Fentanyl; Ketamine; Gabapentin; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment