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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
142
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)
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)
Indiana Univeristy
Indianapolis, Indiana, United States
RECRUITINGIndiana University Hospital
Indianapolis, Indiana, United States
RECRUITINGIV morphine equivalent (MME)
Cumulative Milligrams of morphine equivalent (MME) consumption
Time frame: First 24 hours postoperative
Opioid consumption
Opioid consumption in morphine equivalent (MME)
Time frame: 1 hour after arrival time to post anesthesia care unit
Opioid consumption
Opioid consumption in morphine equivalent (MME)
Time frame: 12 hours after arrival time to post anesthesia care unit
Opioid consumption
Opioid consumption in morphine equivalent (MME)
Time frame: 24 hours after arrival time to post anesthesia care unit
Opioid side effect-Nausea
Incidence of opioid side effects-nausea
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Opioid side effects-Vomiting
Incidence of opioid side effects-vomiting
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Opioid side effects-Pruritis
Incidence of opioid side effects-pruritis
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Adverse Events
Incidence of adverse events
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
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Opioid side effects-Respiratory Depression
Incidence of opioid side effects-respiratory depression
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Pain Scores
Visual Analog Scale (VAS) pain score On a scale of 1 to 10 (increments of 1 unit), 1 being no pain at all, 10 being the most pain the patient has ever experienced
Time frame: 24 hours after arrival time to post anesthesia care unit
Pain Scores
Visual Analog Scale (VAS) pain score On a scale of 1 to 10 (increments of 1 unit), 1 being no pain at all, 10 being the most pain the patient has ever experienced
Time frame: 12 hours after arrival time to post anesthesia care unit