Inrathecal Morphine
DrugIntrathecal 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)
NCT Number: NCT06593665
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.
Interested in participating?
Request Info18 year–80 year
Male
Interventional
Phase 3
Indiana Univeristy, Indianapolis, Indiana, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: First 24 hours postoperative
Cumulative Milligrams of morphine equivalent (MME) consumption
Time frame: 1 hour after arrival time to post anesthesia care unit
Opioid consumption in morphine equivalent (MME)
Time frame: 12 hours after arrival time to post anesthesia care unit
Opioid consumption in morphine equivalent (MME)
Time frame: 24 hours after arrival time to post anesthesia care unit
Opioid consumption in morphine equivalent (MME)
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Incidence of opioid side effects-nausea
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Incidence of opioid side effects-vomiting
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Incidence of opioid side effects-pruritis
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Incidence of adverse events
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Incidence of opioid side effects-respiratory depression
Time frame: 24 hours after arrival time to post anesthesia care unit
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
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
Contact information is provided by the study sponsor or research team.
Angie Plummer
CONTACT
Lyla S Farlow
CONTACT
Indiana University
Other
Randomized Prospective Study Comparing Intrathecal Morphine vs Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection (RPLND)
Acronym: RPLND
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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