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

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Malignant Female Reproductive System Neoplasm

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04258631

NCI-2020-00609 (Registry Identifier)

MC2061 (Other Identifier)

19-010500

Details and patient eligibility

About

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.

Full 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).

Enrollment: 105 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Arm I (laparotomy, liposomal bupivacaine)

Active Comparator group

Description:

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

Treatment:

Procedure: Laparotomy

Drug: Liposomal Bupivacaine

Other: Questionnaire Administration

Arm II (laparotomy, liposomal bupivacaine, hydromorphone)

Experimental group

Description:

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

Treatment:

Drug: Hydromorphone

Procedure: Laparotomy

Drug: Liposomal Bupivacaine

Other: Questionnaire Administration