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NCT04117074 · ClinicalTrials.gov registry record · Phase 3
Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery
A Phase 3 study of Surgery and Analgesia, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
- 1
- Study location
NCT04117074: Completed Phase 3 study of Surgery and Analgesia, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT04117074 is a Phase 3 study of Surgery and Analgesia that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 106 participants, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04117074, a Phase 3 study of Surgery and Analgesia, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to test the hypothesis that surgical site infiltration with liposomal bupivacaine (LB) is non-inferior to and more cost effective than thoracic epidural analgesia (TEA) for patients undergoing open gynecologic surgery on an established enhanced recovery program (ERP) using a non-inferiority randomized trial design. The impact of TEA and surgical site infiltration with LB on neuroendocrine and inflammatory mediators of surgical stress response (SSR) will also be investigated as a translational endpoint.
Primary Outcome
Pain intensity was measured using the Visual Analog Scale (VAS), a 0-10 scale where 0 indicates no pain and 10 indicates worst pain imaginable. VAS scores were assessed hourly from 0 to 48 hours postoperatively. The area under the curve (AUC) was calculated as the sum of hourly VAS scores over 48 hours, yielding a possible range of 0 to 480. Higher scores indicate greater cumulative pain burden and worse outcomes.
Interventions
- DRUG Liposomal bupivacaine
- OTHER Thoracic epidural analgesia (bupivacaine)
Study Locations (1)
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2021-04-14 |
| Est. Completion | 2025-03-17 |
| Phase | Phase 3 |
What the finished NCT04117074 record still lists
NCT04117074 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Surgery appearing as the primary indexed condition, and to 2 interventions - of which Liposomal bupivacaine is the first listed.
NCT04117074 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04117074 about?
NCT04117074 is a clinical study titled "Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery". The goal of this study is to test the hypothesis that surgical site infiltration with liposomal bupivacaine (LB) is non-inferior to and more cost effective than thoracic epidural analgesia (TEA) for patients undergoing open gynecologic surgery on an established enhanced recovery program (ERP) using ...
What is the current status of trial NCT04117074?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2021-04-14. Estimated completion is 2025-03-17.
What conditions does trial NCT04117074 study?
This clinical trial studies the following conditions: Surgery, Analgesia.
What interventions are being tested in trial NCT04117074?
The interventions under investigation include: Liposomal bupivacaine (DRUG), Thoracic epidural analgesia (bupivacaine) (OTHER).
Who is sponsoring clinical trial NCT04117074?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04117074 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04117074's enrollment target sits among peer trials
106 56th of 120 higher than 65 of 120 other Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgery 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.
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