NCT04258631

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Evaluate if no additional intervention is noninferior to intrathecal analgesia (ITA) for postoperative pain experience 24 hours after surgery after laparotomy for gynecological malignancy within an established enhanced recovery pathway which includes incisional liposomal bupivacaine (ILB). II. Evaluate the effect of intrathecal analgesia on patient satisfaction with postoperative analgesia after laparotomy for gynecological malignancy. III. Report the impact of ITA use on cost. IV. Validate the Quality of Recovery (QOR)-15 in our population. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. ARM II: Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone intrathecally (IT).

Conditions

• Malignant Female Reproductive System Neoplasm

Interventions

Type	Name	Description
DRUG	Hydromorphone	Given IT
PROCEDURE	Laparotomy	Undergo laparotomy
DRUG	Liposomal Bupivacaine	Drug
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2020-07-09
• Primary completion: 2023-08-08
• Completion: 2023-08-08
• First posted: 2020-02-06
• Last updated: 2024-10-16
• Results posted: 2024-10-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study