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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathecal Morphine | Other | 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 | Other | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inrathecal Morphine | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| IV morphine equivalent (MME) | Cumulative Milligrams of morphine equivalent (MME) consumption | First 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | Opioid consumption in morphine equivalent (MME) | 1 hour after arrival time to post anesthesia care unit |
| Opioid consumption | Opioid consumption in morphine equivalent (MME) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lyla S Farlow | Contact | 3179489804 | lychrist@iu.edu | |
| Angie Plummer | Contact | 3179447293 | plummera@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gulraj S Chawla, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Univeristy | Recruiting | Indianapolis | Indiana | 46202 | United States |
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A total of 142 subjects will be randomized by a computer program into two groups.
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The primary investigator or his/her designee will inform the anesthesiology team caring for each subject of the arm of the study they are in for each case. Subjects and research staff doing post-operative assessments will be blinded to the randomization.
| Intravenous Methadone | Drug | 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) |
|
| 12 hours after arrival time to post anesthesia care unit |
| Opioid consumption | Opioid consumption in morphine equivalent (MME) | 24 hours after arrival time to post anesthesia care unit |
| Opioid side effect-Nausea | Incidence of opioid side effects-nausea | after arrival time to post anesthesia care unit until 24 hours/completion of study |
| Opioid side effects-Vomiting | Incidence of opioid side effects-vomiting | after arrival time to post anesthesia care unit until 24 hours/completion of study |
| Opioid side effects-Pruritis | Incidence of opioid side effects-pruritis | after arrival time to post anesthesia care unit until 24 hours/completion of study |
| Adverse Events | Incidence of adverse events | after arrival time to post anesthesia care unit until 24 hours/completion of study |
| Opioid side effects-Respiratory Depression | Incidence of opioid side effects-respiratory depression | 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 | 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 | 12 hours after arrival time to post anesthesia care unit |
| Indiana University Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| ID | Term |
|---|---|
| D013736 | Testicular Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
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