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NCT02423876 · ClinicalTrials.gov registry record · Phase 3
Epidural Anesthesia Within an Enhanced Recovery Pathway in Reducing Pain in Patients Undergoing Gynecologic Surgery
A Phase 3 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 3
- Development phase
- 104
- Enrollment target
NCT02423876: Completed Phase 3 study, sponsored by University of Wisconsin, Madison.
NCT02423876 is a Phase 3 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 104 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02423876, a Phase 3 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 104 participants
- Enrollment target
Study Summary
This randomized clinical trial studies epidural anesthesia within an enhanced recovery pathway (ERP) in reducing pain in patients undergoing gynecologic surgery. An epidural analgesia (pain relief) is a small tube placed in the lower back that numbs the nerves and stops the feeling of pain. It stays in place for several days after surgery and may be helpful for pain control in patients with gynecologic cancer after surgery. ERP is a set of specific steps used before, during, and after surgery by health care providers to care for patients after surgery. ERPs include patient education, not using laxatives before surgery, increasing activity after surgery, and scheduled use of medications for pain and nausea. Giving epidural anesthesia as part of an ERP may improve pain control in patients undergoing gynecologic surgery.
Primary Outcome
Relative pain scores between the epidural and non-epidural group will be analyzed by calculating a two-sided 95% confidence interval on the difference in mean scores between the two groups and concluding non-inferiority if this lies entirely below 2 points (mean non-epidural pain score proven, within a 95% confidence limit, to be at most 2 points worse than mean pain score in the epidural group). NRS rates pain on a 1-10 scale, with 1 being no pain, and 10 being the worst pain imaginable.
Interventions
- DRUG Epidural analgesia
- OTHER Intraoperative Complication Management and Prevention
- PROCEDURE Pain Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2015-03-17 |
| Est. Completion | 2022-01-03 |
| Phase | Phase 3 |
What the finished NCT02423876 record still lists
NCT02423876 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Epidural analgesia is the first listed.
NCT02423876 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02423876 about?
NCT02423876 is a clinical study titled "Epidural Anesthesia Within an Enhanced Recovery Pathway in Reducing Pain in Patients Undergoing Gynecologic Surgery". This randomized clinical trial studies epidural anesthesia within an enhanced recovery pathway (ERP) in reducing pain in patients undergoing gynecologic surgery. An epidural analgesia (pain relief) is a small tube placed in the lower back that numbs the nerves and stops the feeling of pain. It stays...
What is the current status of trial NCT02423876?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 104 participants. The study started on 2015-03-17. Estimated completion is 2022-01-03.
What interventions are being tested in trial NCT02423876?
The interventions under investigation include: Epidural analgesia (DRUG), Intraoperative Complication Management and Prevention (OTHER), Pain Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT02423876?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02423876's enrollment target sits among peer trials
104 1671st of 2000 higher than 327 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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