Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway
Condition: Malignant Neoplasms of Female Genital Organs; Gynecologic Cancer
MeSH terms: Neoplasms; Genital Neoplasms, Female
Intervention: Bupivacaine; Liposomal Bupivacaine; Oxycodone; Pill Diary; Symptom Questionnaire
Intervention description: 150 mg (0.25%) injected on each side of the wound at the end of surgery before wound closure.; 266 mg injected on each side of the wound at the end of surgery before wound closure.; 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain.; Participants complete a pill diary every day for 30 days after hospital discharge.; Participants called or emailed and asked questions about symptoms three (3) and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
Intervention MeSH terms: Oxycodone; Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 105.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Malignant neoplasms of female genital organs; Open gynecologic surgery; Local wound infiltration; Gynecologic cancer; Bupivacaine; Liposomal Bupivacaine; Oxycodone; ETH-Oxydose [DSC]; OxyContin; OxyIR; Roxicodone; Questionnaires; Surveys; MD Anderson Symptom Inventory; MDASI; Pill diary; Medication log

Summary:

      Bupivacaine is a drug that is traditionally given as an injection to numb surgical sites.
      Liposomes are molecules that are similar to fats. Sometimes drugs are combined with liposomes
      to make them able to stay in the body for longer periods of time. This has been done with
      bupivacaine to create liposomal bupivacaine.

      The goal of this clinical research study is to compare the effects of bupivacaine to those of
      liposomal bupivacaine when given to patients who are having gynecologic surgery. Researchers
      want to compare how long the drugs work to numb the wound and how long patients take to
      recover from surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Undergoing an exploratory laparotomy for suspected gynecologic cancer, which includes
             metastatic disease from neoplasia originating in other organs

          2. Planned participation in the Gynecologic Enhanced Recovery Pathway

          3. Female 18 years of age or older

          4. Patient must be able to read and speak English

          5. Consents to being part of a randomized, single-blinded study

          6. Patient has physical and mental capabilities to take part in study

          7. Bilirubin less than or equal to 1.5 x upper limit of the normal range (ULN); Serum
             Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic Transaminase
             (SGPT) </=2.5 x ULN

          8. If the patient is of childbearing potential, the patient must have a negative blood or
             urine pregnancy test within 14 days of surgical treatment on study

        Exclusion Criteria:

          1. Sensitivity to amide-type local anesthetics

          2. Patients on long-acting opioid medications, or scheduled (four or more times a day for
             seven or more days) short-acting opioid medications within the last 30 days

          3. Emergency surgery of any type that does not allow for proper time for protocol review
             by the patient

          4. Surgery that involves known/anticipated resection of anterior abdominal wall with
             plastic surgery reconstruction

          5. Patients undergoing pelvic exenteration

          6. Patients undergoing known/anticipated anterior abdominal wall hernia repairs

          7. Patients weighing <50 kg