A Study to Evaluate Wound Infiltration with Liposomal Bupivacaine in Laparotomy for Gynecological Malignancy

Overview

About this study

The purpose of this study is to determine whether or not there is a benefit to adding opioid injection around the spinal cord ( intrathecal) to incisional long-acting local anesthetic (liposomal bupivacaine) injection for pain management after abdominal surgery for gynecological cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age > 18 and ≤ 80 years old.
  • Elective surgery for suspected (based on consulting surgeon’s opinion - imaging, lab, path) gynecological malignancy, 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 postop pain):
    • Planned ICU admission, abdominoperineal resection, exenteration, use of IORT, HIPEC.
  • Contraindication to neuraxial analgesia:
    • Coagulopathy:
      • INR >1.2 Current or predicted after surgery (e.g., planned right hepatic resection);
      • Thrombocytopenia (plts < 100);
      • Hemophiliac disease states (hemophilia, von Willebrand disease, etc.);
      • Patients receiving antithrombotic or thrombolytic therapy are excluded according to the ASRA guidelines (Reference: https://rapm.bmj.com/content/rapm/43/3/263.full.pdf).
    • 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 (GFR less than 30 ml/min per 1.73 m^2).
  • Intolerance or allergy to opioids, acetaminophen, or amide-type local anesthetics.
  • Current pregnancy.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sean Dowdy, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20476554

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