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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, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. 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.
Primary Outcome
Number of participants undergoing lumbar spine surgery with complete follow-up
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 |
What the finished NCT03088306 record still lists
NCT03088306 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Standard analgesia use [Oxygen] is the first listed.
NCT03088306 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03088306's enrollment target sits among peer trials
49 534th of 2000 higher than 1,461 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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