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Liposomal Bupivacaine With or Without Hydromorphone for the Improvement of Pain Control After Laparotomy in Patients With Gynecological Malignancies

NCT04258631 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-10-16

Study results available
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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.

Conditions

  • Malignant Female Reproductive System Neoplasm

Interventions

DRUG

Hydromorphone

Given IT

PROCEDURE

Laparotomy

Undergo laparotomy

DRUG

Liposomal Bupivacaine

Drug

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

Principal Investigators

  • Sean C Dowdy · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2023-08-08
Completion
2023-08-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04258631 on ClinicalTrials.gov