Randomized Prospective Study Comparing Intrathecal Morphine vs Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection (RPLND)
Indiana University
Summary
This randomization study is to compare both intrathecal morphine and intravenous methadone, which are both standard of care, for pain management in patients undergoing retroperitoneal lymph node dissections for primary testicular cancer. Investigators plan to compare their analgesic effectiveness at different postoperative time intervals.
Description
In this study, investigators aim to compare intravenous methadone combined with standard multimodal analgesia and surgical infiltration of local anesthesia to intrathecal duramorph with standard multimodal analgesia and surgical infiltration of local anesthesia. In this single blinded prospective randomized control trial, investigators hypothesize that intravenous methadone will provide a significant reduction in patient opioid consumption when compared to intrathecal opioid analgesia in the first 24 hours in patients who undergo PC/RPLND.
Eligibility
- Age range
- 18–80 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Patients undergoing a virgin (chemotherapy has not been used) or post- chemotherapy retroperitoneal lymph node dissection for primary testicular cancer at IU Health AAHC * ASA Class 1, 2, 3 * Age 18 to 80 years; Male * BMI less than 50kg/m2 Exclusion Criteria: * Any contraindication for neuraxial analgesia * Patient on home methadone at any dose * Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery. * Known true allergy to the study medications (morphine, bupivacaine,…
Interventions
- DrugInrathecal Morphine
Intrathecal preservative free morphine (duramorph) 200 mcg with 7.5mg of hyperbaric bupivacaine placed by a spinal needle prior to induction of general anesthesia (n=71)
- DrugIntravenous Methadone
Intravenous methadone dosed at 0.2 mg/kg Ideal Body weight up to a maximum dose of 20mg, rounded to the nearest milligram, for all patients given during the induction of general anesthesia (n=71)
Locations (2)
- Indiana UniveristyIndianapolis, Indiana
- Indiana University HospitalIndianapolis, Indiana