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

NCT ID: NCT04258631

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-09
• Study Completion Date: 2023-08-08

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (laparotomy, liposomal bupivacaine)

Patients undergo standard of care laparotomy and then receive liposomal bupivacaine.

Group Type: ACTIVE_COMPARATOR

Laparotomy

Intervention Type: PROCEDURE

Undergo laparotomy

Liposomal Bupivacaine

Intervention Type: DRUG

Drug

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Arm II (laparotomy, liposomal bupivacaine, hydromorphone)

Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT.

Group Type: EXPERIMENTAL

Hydromorphone

Intervention Type: DRUG

Given IT

Laparotomy

Intervention Type: PROCEDURE

Undergo laparotomy

Liposomal Bupivacaine

Intervention Type: DRUG

Drug

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Hydromorphone

Given IT

Intervention Type: DRUG

Laparotomy

Undergo laparotomy

Intervention Type: PROCEDURE

Liposomal Bupivacaine

Drug

Intervention Type: DRUG

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

(-)-Hydromorphone; Dihydromorphinone; Hydromorphon; Bupivacaine Liposome Injectable Suspension; Exparel

Eligibility Criteria

Inclusion Criteria

• Elective surgery for suspected (based on consulting surgeon's opinion-imaging, laboratory [lab], pathology [path]) gynecological malignancy, enhanced recovery after surgery (ERAS) protocol

Exclusion Criteria

• Inability to read or understand English
• Prehospitalization narcotic use if weekly average daily oral morphine equivalent of > 20 mg
• Chronic pain syndromes such as fibromyalgia
• Extensive surgery planned (surrogate for post-operative [postop] pain): Planned intensive care unit (ICU) admission, abdominoperineal resection, exenteration, use of intraoperative radiation (IORT), hyperthermic intraperitoneal chemotherapy (HIPEC)
• Contraindication to neuraxial analgesia:

• Coagulopathy

• International normalized ratio (INR) > 1.2 current or predicted after surgery (e.g. planned right hepatic resection)
• Thrombocytopenia. Platelets (plts) < 100
• Hemophiliac disease states (hemophilia, von Willebrand disease, etc.)
• Patients receiving antithrombotic or thrombolytic therapy are excluded according to the American Society of Regional Anesthesia and Pain Medicine (ASRA) guidelines
• Localized infection at the potential site of injection
• Significant developmental or structural spinal abnormalities that would preclude a safe spinal technique. These include spina bifida, tethered spinal cord, lumbar spinal fusion, and active lumbar radiculopathy
• Patients with stage 4 or 5 kidney disease (glomerular filtration rate [GFR] less than 30 ml/min per 1.73 m^2)
• Intolerance or allergy to opioids, acetaminophen, or amide-type local anesthetics
• Current pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean C Dowdy

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2020-00609

Identifier Type: REGISTRY

Identifier Source: secondary_id

19-010500

Identifier Type: OTHER

Identifier Source: secondary_id

MC2061

Identifier Type: OTHER

Identifier Source: secondary_id

MC2061

Identifier Type: -

Identifier Source: org_study_id