drugset / Trial / NCT04258631

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

NCT04258631

Phase 4 Completed 105 enrolled Mayo Clinic
RandomizedParallel-groupOpen-labelSupportive care

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.

Timeline

Start
2020-07-09
Primary completion
2023-08-08
Completion
2023-08-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydromorphone Other / unclassified Intrathecal
Background Bupivacaine Other / unclassified Other