This phase II trial compares the effect of morphine before surgery (preoperative) and lidocaine during surgery (intraoperative) to standard of care bupivacaine epidural anesthesia intraoperative with hydromorphone patient-controlled anesthesia after surgery (postoperative) to decrease postoperative opioid consumption in patients undergoing a laparotomy. Morphine is an opioid used to control pain. Lidocaine is a local anesthetic used to relieve pain by blocking signals at the nerve endings in skin. Bupivacaine is a local anesthetic used to relieve pain by blocking signals at nerve endings. Hydromorphone is a semi-synthetic opioid used to control pain. Giving preoperative morphine and intraoperative lidocaine may decrease postoperative opioid consumption, control patient’s pain, allow early feeding, early movement, and allow better fluid status in patients undergoing a laparotomy compared to the standard of care treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05017246.
PRIMARY OBJECTIVE:
I. To compare the morphine milligram equivalent (MME) consumption in the postoperative hospital course among patients undergoing laparotomy by the gynecologic oncology service who receive intraoperative lidocaine (IML) versus epidural anesthesia with patient-controlled anesthesia (PCA) (EPCA).
SECONDARY OBJECTIVES:
I. To compare the two treatment groups with respect to:
Ia. Postoperative ileus rate.
Ib. Hospital length of stay.
Ic. Postoperative hypotension.
Id. Patient satisfaction with pain control.
Ie. Pain scores pre-op, post-op day 1, 2 weeks follow-up and 6 week follow-up.
If. 30 day readmission rate.
Ig. Rates of deep venous thrombosis (DVT) and pulmonary thromboembolism (PTE) (collected from day of surgery to 6 weeks after surgery).
Ih. Rate of persistent pain at 6 week follow-up.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Participants receive morphine intrathecally (IT) on the day of surgery and lidocaine intravenously (IV) during surgery.
ARM II: Participants receive standard of care EPCA (bupivacaine epidural during surgery and hydromorphone PCA after surgery).
After completion of study, participants are followed up for 2 and 6 weeks after surgery.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorPremal H. Thaker
