RecruitingPhase 3NCT06593665

Intrathecal Morphine Versus Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection.

Randomized Prospective Study Comparing Intrathecal Morphine vs Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection (RPLND)


Sponsor

Indiana University

Enrollment

142 participants

Start Date

Sep 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two pain management methods after surgery to remove lymph nodes from the abdomen (retroperitoneal lymph node dissection) for testicular cancer: morphine injected into the spinal fluid versus methadone given through an IV. **You may be eligible if...** - You are a male between 18 and 80 years old - You are scheduled for retroperitoneal lymph node dissection for testicular cancer - Your BMI is under 50 - Your overall health falls within acceptable anesthesia risk levels (ASA class 1-3) **You may NOT be eligible if...** - You have any reason you cannot safely receive spinal anesthesia - You currently take methadone at home - You have a drug or opioid use history in the past 6 months - You have severe liver or kidney disease - You are allergic to morphine, bupivacaine, acetaminophen, or methadone - You are already taking more than 30 mg of oral morphine equivalents per day Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Univeristy

Indianapolis, Indiana, United States

Indiana University Hospital

Indianapolis, Indiana, United States

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NCT06593665


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