Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway
Malignant Neoplasms of Female Genital Organs, Gynecologic Cancer
About this trial
This is an interventional treatment trial for Malignant Neoplasms of Female Genital Organs focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- Undergoing an exploratory laparotomy for suspected gynecologic cancer, which includes metastatic disease from neoplasia originating in other organs
- Planned participation in the Gynecologic Enhanced Recovery Pathway
- Female 18 years of age or older
- Patient must be able to read and speak English
- Consents to being part of a randomized, single-blinded study
- Patient has physical and mental capabilities to take part in study
- 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
- 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:
- Sensitivity to amide-type local anesthetics
- 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
- Emergency surgery of any type that does not allow for proper time for protocol review by the patient
- Surgery that involves known/anticipated resection of anterior abdominal wall with plastic surgery reconstruction
- Patients undergoing pelvic exenteration
- Patients undergoing known/anticipated anterior abdominal wall hernia repairs
- Patients weighing <50 kg
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Bupivacaine Group
Liposomal Bupivacaine + Bupivacaine Group
Local wound infiltration with Bupivacaine immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 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.
Local wound infiltration with Liposomal Bupivacaine and 0.25% Bupivacaine admixed immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 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.