Randomized Prospective Study Comparing Intrathecal Morphine vs Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection (RPLND)
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.
Detailed 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.
Arms & 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)
Outcome measures
Primary
IV morphine equivalent (MME)
Cumulative Milligrams of morphine equivalent (MME) consumption
Time frame: First 24 hours postoperative
Secondary
Opioid consumption
Time frame: 1 hour after arrival time to post anesthesia care unit
Opioid consumption
Time frame: 12 hours after arrival time to post anesthesia care unit
Opioid consumption
Time frame: 24 hours after arrival time to post anesthesia care unit
Opioid side effect-Nausea
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Opioid side effects-Vomiting
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Opioid side effects-Pruritis
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Adverse Events
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Opioid side effects-Respiratory Depression
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Pain Scores
Time frame: 24 hours after arrival time to post anesthesia care unit
Pain Scores
Time frame: 12 hours after arrival time to post anesthesia care unit
Eligibility criteria
Study locations (2)
Indiana Univeristy
Indianapolis, Indiana, 46202
Indiana University Hospital
Indianapolis, Indiana, 46202