This phase III trial compares thoracic epidural analgesia (TEA) to surgical site infiltration with liposomal bupivacaine in treating pain in patients undergoing gynecologic surgery. Using an epidural (an infusion of pain medication [bupivacaine] into the spinal column) after surgery has been shown to help control pain and decrease the amount of pain medication needed by mouth. Injection of the surgical incision with the long acting anesthetic (pain medication) called liposomal bupivacaine has also been shown to be beneficial for pain control and to decrease the amount of pain medication needed by mouth. Surgical site infiltration with liposomal bupivacaine may work the same as TEA in controlling pain after surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04117074.
PRIMARY OBJECTIVE:
I. Mean Overall Benefit of Analgesic Score (OBAS) during the first 48 hours (h) postoperatively will be compared between the two treatment groups.
SECONDARY OBJECTIVES:
I. Opioid requirements in oral (PO) morphine equivalents during the first 48 h postoperatively and during the entirety of the inpatient postoperative hospital stay.
II. Mean pain scores on a numeric/visual analog scale at rest and when moving (coughing) in the morning and evening during the first 48 h postoperatively.
III. Mean patient-perceived quality of recovery score during the first 48 h postoperatively.
IV. Time to return of bowel function (ROBF) and incidence of postoperative ileus.
V. Level of mobilization.
VI. Degree of sedation.
VII. Length of hospital stay.
VIII. Time to postoperative diuresis defined as the time lapse from day of surgery (DOS) to a net negative fluid balance sustained over a 24 h period.
IX. Incidence of major postoperative complications including 30-day hospital readmission.
X. Postoperative Quality of Recovery after Surgery (PQRS) score on postoperative day 2.
XI. Post-discharge narcotic utilization.
XII. Total direct costs associated with loco-regional anesthesia.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive thoracic epidural analgesia with bupivacaine via infusion during and after surgery.
ARM II: Patients receive liposomal bupivacaine via injection to the surgical site after surgery.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorRebecca Lynn Stone
