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NCT03088306 · ClinicalTrials.gov registry record · Early Phase 1
Improving Pain and Reducing Opioid Use (IPaRO) in Lumbar Spine Surgery Patients
A Early Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 49
- Enrollment target
NCT03088306: Completed Early Phase 1 study, sponsored by Johns Hopkins University.
NCT03088306 is a Early Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 49 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03088306, a Early Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 49 participants
- Enrollment target
Study 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.
Interventions
- DRUG Standard analgesia use [Oxygen]
- DRUG Standard analgesia use [Hydromorphone]
- DRUG Standard analgesia use [Volatile Anesthesia]
- DRUG Standard analgesia use [Fentanyl]
- DRUG Multi-modal pain management [Acetaminophen + Gabapentin]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2018-08-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03088306
The ClinicalTrials.gov registry entry for NCT03088306 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Standard analgesia use [Oxygen] is the first listed.
NCT03088306 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03088306 about?
NCT03088306 is a clinical study titled "Improving Pain and Reducing Opioid Use (IPaRO) in Lumbar Spine Surgery Patients". 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 m...
What is the current status of trial NCT03088306?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 49 participants. The study started on 2017-07-01. Estimated completion is 2018-08-31.
What interventions are being tested in trial NCT03088306?
The interventions under investigation include: Standard analgesia use [Oxygen] (DRUG), Standard analgesia use [Hydromorphone] (DRUG), Standard analgesia use [Volatile Anesthesia] (DRUG), Standard analgesia use [Fentanyl] (DRUG), Multi-modal pain management [Acetaminophen + Gabapentin] (DRUG).
Who is sponsoring clinical trial NCT03088306?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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