NCT03088306

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lumbar Spinal Stenosis
• Lumbar Spinal Instability
• Lumbar Spine Degeneration

Interventions

Type	Name	Description
DRUG	Standard analgesia use [Oxygen]	A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.
DRUG	Standard analgesia use [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.
DRUG	Standard analgesia use [Volatile Anesthesia]	A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.
DRUG	Standard analgesia use [Fentanyl]	A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.
DRUG	Multi-modal pain management [Acetaminophen + Gabapentin]	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.
DRUG	Multi-modal pain management [Fentanyl]	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.
DRUG	Multi-modal pain management [Intravenous Ketamine]	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.
DRUG	Multi-modal pain management [Valium + Gabapentin]	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.

Timeline

• Start date: 2017-07-01
• Primary completion: 2018-05-31
• Completion: 2018-08-31
• First posted: 2017-03-23
• Last updated: 2018-10-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study