Phase 4 N=105 Randomized Supportive Care

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

Malignant Female Reproductive System Neoplasm

Bottom Line

View on ClinicalTrials.gov: NCT04258631 ↗

Enrolled (actual)

105

Serious AEs

1.0%

Results posted

Oct 2024

Primary outcome: Primary: Overall Benefit of Analgesia Score (OBAS) — 4; 4 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Hydromorphone (Drug); Laparotomy (Procedure); Liposomal Bupivacaine (Drug); Questionnaire Administration (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Mayo Clinic
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Benefit of Analgesia Score (OBAS)	4; 4	—
SECONDARY Cumulative 24-hour Narcotic Consumption	41.4; 17.5	—
SECONDARY Post-operative Pain Scores	4; 3	—
SECONDARY Time to First Analgesic Request	20.1; 25.0	—
SECONDARY Use of Intravenous (IV) Patient-controlled Analgesia	3; 5	—
SECONDARY Use of Intravenous Rescue Opioids	42; 12	—
SECONDARY Length of Stay	3.8; 3.4	—
SECONDARY Additional Fluid Requirement After 24 Hours of Surgery	27; 24	—
SECONDARY Weight Gain Following Surgery	—	—
SECONDARY Total Cost of Care	30109; 27776	—
SECONDARY Incidence of Adverse Events	0; 1	—
SECONDARY Operating Room Time	6.2; 5.8	—
SECONDARY Surgical Time	4.5; 4.4	—
SECONDARY Pain Management	830; 807	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04258631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.