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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04258631
The ClinicalTrials.gov registry entry for NCT04258631 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Questionnaire Administration is the first listed.
NCT04258631 reports 0 study locations.
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.
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