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NCT02104414 · ClinicalTrials.gov registry record · Phase 4
Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy
A Phase 4 study, sponsored by St. Luke's-Roosevelt Hospital Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT02104414: Clinical Trial Phase 4 study, sponsored by St. Luke's-Roosevelt Hospital Center.
NCT02104414 is a Phase 4 study that was terminated before completion, run by St. Luke's-Roosevelt Hospital Center. The registered enrollment target is 11 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02104414, a Phase 4 study, was terminated before completion, sponsored by St. Luke's-Roosevelt Hospital Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the quality and duration of pain relief after a hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more effective postoperative pain relief than both bupivacaine hcl and the control.
Primary Outcome
The primary objective is to evaluate analgesia following local infiltration of 30 mL Exparel or the same volume of 0.25% bupivacaine HCl with epinephrine or normal saline. The intensity of pain will be measured using a numerical rating scale (NRS-11) in which 0 represents no pain, and 10 represents extreme pain.
Interventions
- DRUG Exparel
- DRUG Normal Saline
- DRUG Bupivacaine HCl with Epinephrine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-01 |
| Phase | Phase 4 |
Why NCT02104414 stopped before completion
NCT02104414 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Exparel is the first listed.
NCT02104414 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02104414 about?
NCT02104414 is a clinical study titled "Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy". The purpose of this study is to compare the quality and duration of pain relief after a hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more effective postoperative pain...
What is the current status of trial NCT02104414?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2014-04. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02104414?
The interventions under investigation include: Exparel (DRUG), Normal Saline (DRUG), Bupivacaine HCl with Epinephrine (DRUG).
Who is sponsoring clinical trial NCT02104414?
This trial is sponsored by St. Luke's-Roosevelt Hospital Center, which has 57 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02104414's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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