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NCT04258631 · ClinicalTrials.gov registry record · Phase 4
Liposomal Bupivacaine With or Without Hydromorphone for the Improvement of Pain Control After Laparotomy in Patients With Gynecological Malignancies
A Phase 4 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 105
- Enrollment target
NCT04258631: Completed Phase 4 study, sponsored by Mayo Clinic.
NCT04258631 is a Phase 4 study that has completed, run by Mayo Clinic. The registered enrollment target is 105 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04258631, a Phase 4 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 105 participants
- Enrollment target
Study Summary
This phase IV trial studies how well liposomal bupivacaine with or without hydromorphone works in improving pain control during the first 24 hours after surgery in patients with gynecological malignancies undergoing laparotomy. Liposomal bupivacaine is routinely infiltrated into the skin surrounding the abdominal incision, and is effective in providing good relief of incisional pain. Hydromorphone is also a type of pain medication that may provide better management of deep abdominal pain. It is not yet known if giving liposomal bupivacaine with or without hydromorphone will work better in improving pain in patients with gynecological malignancies during the first 24 hours after surgery.
Primary Outcome
The Overall Benefit of Analgesia Score (OBAS) is a multi-dimensional survey that measures a patient's benefit from postoperative pain therapy. It assesses pain intensity, opioid-related adverse events, and patient satisfaction with analgesia. Each of 7 questions are scored on a scale from 0 to 4 where 0=minimal/not at all and 4=maximum/very much. The total score is a sum of the 7 item scores with question 7 scored as 4 minus the patient reported number. Total scores range from 0 to 28 with lower
Interventions
- OTHER Questionnaire Administration
- DRUG Liposomal Bupivacaine
- DRUG Hydromorphone
- PROCEDURE Laparotomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2020-07-09 |
| Est. Completion | 2023-08-08 |
| Phase | Phase 4 |
What the finished NCT04258631 record still lists
NCT04258631 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 4 interventions - of which Questionnaire Administration is the first listed.
NCT04258631 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04258631 about?
NCT04258631 is a clinical study titled "Liposomal Bupivacaine With or Without Hydromorphone for the Improvement of Pain Control After Laparotomy in Patients With Gynecological Malignancies". This phase IV trial studies how well liposomal bupivacaine with or without hydromorphone works in improving pain control during the first 24 hours after surgery in patients with gynecological malignancies undergoing laparotomy. Liposomal bupivacaine is routinely infiltrated into the skin surrounding...
What is the current status of trial NCT04258631?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 105 participants. The study started on 2020-07-09. Estimated completion is 2023-08-08.
What interventions are being tested in trial NCT04258631?
The interventions under investigation include: Questionnaire Administration (OTHER), Liposomal Bupivacaine (DRUG), Hydromorphone (DRUG), Laparotomy (PROCEDURE).
Who is sponsoring clinical trial NCT04258631?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04258631's enrollment target sits among peer trials
105 749th of 2000 higher than 1,247 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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