CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 105 enrolled
Drug / intervention
Hydromorphone +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04258631
NCT04258631Phase 4Completed

Wound Infiltration With Liposomal Bupivacaine With or Without Intrathecal Analgesia in Laparotomy for Gynecological Malignancy: A Randomized Controlled Trial

Mayo Clinic·interventional·Posted Feb 6, 2020·Updated Oct 16, 2024

In Brief

A Phase 4 clinical trial evaluating Hydromorphone, Laparotomy, and 2 other interventions for Malignant Female Reproductive System Neoplasm. Completed, enrolled 105 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedFeb 6, 2020
Enrollment StartJul 9, 2020
Primary CompletionAug 8, 2023
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.4 years ago

Interventions

Hydromorphonedrug

Given IT

Laparotomyprocedure

Undergo laparotomy

Liposomal Bupivacainedrug

Drug

Questionnaire Administrationother

Ancillary studies