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

NCT04258631 | Completed Phase 4 Results DMC FDA Drug

• 3 other identifiers: MC2061NCI-2020-0060919-010500
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Female Reproductive System Neoplasm

Outcome Measures

Primary Outcomes (1)

• Overall Benefit of Analgesia Score (OBAS)

  The Overall Benefit of Analgesia Score (OBAS) is a multi-dimensional survey that measures a patient's benefit from postoperative pain therapy. It assesses pain intensity, opioid-related adverse events, and patient satisfaction with analgesia. Each of 7 questions are scored on a scale from 0 to 4 where 0=minimal/not at all and 4=maximum/very much. The total score is a sum of the 7 item scores with question 7 scored as 4 minus the patient reported number. Total scores range from 0 to 28 with lower scores representing greater benefit from analgesic therapy. The median total OBAS score for each group is presented.

  Up to 24 hours after surgery

Secondary Outcomes (13)

• Cumulative 24-hour Narcotic Consumption

  Up to 24 hours after surgery

• Post-operative Pain Scores

  Up to 24 hours after surgery

• Time to First Analgesic Request

  Up to 24 hours after surgery

• Use of Intravenous (IV) Patient-controlled Analgesia

  Up to 24 hours after surgery

• Use of Intravenous Rescue Opioids

  Up to 24 hours after surgery

Other Outcomes (1)

• Quality of Recovery-15 (QoR-15) Total Score

  At 24 hours after surgery

Study Arms (2)

Arm I (laparotomy, liposomal bupivacaine)

ACTIVE COMPARATOR

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

Procedure: Laparotomy; Drug: Liposomal Bupivacaine; Other: Questionnaire Administration

Arm II (laparotomy, liposomal bupivacaine, hydromorphone)

EXPERIMENTAL

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

Drug: Hydromorphone; Procedure: Laparotomy; Drug: Liposomal Bupivacaine; Other: Questionnaire Administration

Interventions

Hydromorphone DRUG

Given IT

Also known as: (-)-Hydromorphone, Dihydromorphinone, Hydromorphon

Arm II (laparotomy, liposomal bupivacaine, hydromorphone)

Laparotomy PROCEDURE

Undergo laparotomy

Arm I (laparotomy, liposomal bupivacaine); Arm II (laparotomy, liposomal bupivacaine, hydromorphone)

Liposomal Bupivacaine DRUG

Drug

Also known as: Bupivacaine Liposome Injectable Suspension, Exparel

Arm I (laparotomy, liposomal bupivacaine); Arm II (laparotomy, liposomal bupivacaine, hydromorphone)

Questionnaire Administration OTHER

Ancillary studies

Arm I (laparotomy, liposomal bupivacaine); Arm II (laparotomy, liposomal bupivacaine, hydromorphone)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Hydromorphone; Laparotomy

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Surgical Procedures, Operative

Results Point of Contact

• Title: Sean C. Dowdy, M.D.
• Organization: Mayo Clinic

Dowdy.Sean@mayo.edu

507-266-0225

Study Officials

• Sean C Dowdy

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: July 9, 2020
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: October 16, 2024
• Results First Posted: October 16, 2024

Record last verified: 2024-10

Locations

US (1)