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NCT01546948 · ClinicalTrials.gov registry record · Phase 4
Intraoperative Opioids and Postoperative Recovery After Hepatobiliary or Foregut Surgery
A Phase 4 study, sponsored by Endeavor Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT01546948: Completed Phase 4 study, sponsored by Endeavor Health.
NCT01546948 is a Phase 4 study that has completed, run by Endeavor Health. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01546948, a Phase 4 study, has completed, sponsored by Endeavor Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
The primary aim of this randomized, double-blind study is to examine the effect of a single intraoperative dose of methadone on analgesic requirements during the first three days after hepatobiliary or foregut surgery. These patients will be compared to subjects receiving a standard dose of the "traditional" intraoperative opioid (hydromorphone). Secondary outcome measures to be assessed will include postoperative pain scores and standard recovery variables such as hospital length of stay.
Primary Outcome
A blinded research assistant will record the total doses of hydromorphone used in the PACU and with the PCA device during the first 24, 48, and 72 hour after surgery.
Interventions
- DRUG Methadone
- DRUG Hydromorphone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-08 |
| Est. Completion | 2018-06 |
| Phase | Phase 4 |
What the finished NCT01546948 record still lists
NCT01546948 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Methadone is the first listed.
NCT01546948 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01546948 about?
NCT01546948 is a clinical study titled "Intraoperative Opioids and Postoperative Recovery After Hepatobiliary or Foregut Surgery". The primary aim of this randomized, double-blind study is to examine the effect of a single intraoperative dose of methadone on analgesic requirements during the first three days after hepatobiliary or foregut surgery. These patients will be compared to subjects receiving a standard dose of the "tra...
What is the current status of trial NCT01546948?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2011-08. Estimated completion is 2018-06.
What interventions are being tested in trial NCT01546948?
The interventions under investigation include: Methadone (DRUG), Hydromorphone (DRUG).
Who is sponsoring clinical trial NCT01546948?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01546948's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 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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