An Early Phase 1 interventional study of Standard analgesia use [Oxygen] and Standard analgesia use [Hydromorphone] in Lumbar Spinal Stenosis, Lumbar Spinal Instability and Lumbar Spine Degeneration, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-10-16.
Sponsored by Johns Hopkins University · Early Phase 1, Interventional, and Treatment
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.
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.
459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.
This study's enrollment of 49 is below the median of 80 across 283 interventional studies indexed under Spinal Stenosis.
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Exclusion Criteria:
A strategy to manage pain in the peri-operative period that is in common clinical use.
Drug: Standard analgesia use [Oxygen] · Drug: Standard analgesia use [Hydromorphone] · Drug: Standard analgesia use [Volatile Anesthesia] · Drug: Standard analgesia use [Fentanyl]
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.
Drug: Multi-modal pain management [Acetaminophen + Gabapentin] · Drug: Multi-modal pain management [Fentanyl] · Drug: Multi-modal pain management [Intravenous Ketamine] · Drug: Multi-modal pain management [Valium + Gabapentin]
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.
Number of participants undergoing lumbar spine surgery with complete follow-up
Number of participants undergoing lumbar spine surgery with complete follow-up
Time frame: 52 week
Patient controlled analgesia (PCA) pump use
Total morphine equivalent of opioids administered by the PCA pump
Time frame: during surgical hospitalization, up to 12 weeks
Opioid medication use
How many patients were prescribed and using opioid medication over the 90 days after hospital discharge?
Time frame: up to 90 days
Patient Reported Outcomes Measurement Information System (PROMIS) Pain
Measure of pain intensity; Range 0 - 100; Population mean 50, standard deviation 10
Time frame: at 6 and 12 weeks
PROMIS Physical Function
Measure of physical function; Range 0 - 100; Population mean 50, standard deviation 10
Time frame: at 6 and 12 weeks
PROMIS Fatigue
Measure of fatigue; Range 0 - 100; Population mean 50, standard deviation 10
Time frame: at 6 and 12 weeks
PROMIS Anxiety
Measure of anxiety; Range 0 - 100; Population mean 50, standard deviation 10
Time frame: at 6 and 12 weeks
PROMIS Depression
Measure of depression; Range 0 - 100; Population mean 50, standard deviation 10
Time frame: at 6 and 12 weeks
PROMIS Sleep Disturbance
Measure of sleep disturbance; Range 0 - 100; Population mean 50, standard deviation 10
Time frame: at 6 and 12 weeks
PROMIS Satisfaction with Social Roles
Measure of satisfaction with social roles; Range 0 - 100; Population mean 50, standard deviation 10
Time frame: at 6 and 12 weeks
Health status (Medical Outcome Study Short Form 12, version 2)
Measure of physical and mental health; Range 0 - 100; Population mean 50, standard deviation 10
Time frame: at 6 and 12 weeks
Oswestry Disability Index (ODI)
Measure of pain-related disability; Range 0% - 100%; Scores greater than 30% indicative of moderate pain-related disability
Time frame: at 6 and 12 weeks
Plan to share: No
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