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

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

Recruiting
18-80 years
Male
Phase 3

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Overview

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.

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.

Eligibility

Inclusion Criteria:

  • Patients undergoing a virgin (chemotherapy has not been used) or post- chemotherapy retroperitoneal lymph node dissection for primary testicular cancer at IU Health AAHC
  • ASA Class 1, 2, 3
  • Age 18 to 80 years; Male
  • BMI less than 50kg/m2

Exclusion Criteria:

  • Any contraindication for neuraxial analgesia
  • Patient on home methadone at any dose
  • Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
  • Known true allergy to the study medications (morphine, bupivacaine, acetaminophen, methadone)
  • Any history of substance abuse in the past 6 months which would include heroin or any other illegal street drugs
  • End stage liver disease, end stage renal disease
  • Patient staying intubated after surgery
  • Patient (home dose) taking more than 30mg PO morphine equivalent (PME) per day
  • Any additional surgical procedures to the patient with a different surgical incision compared to the standard laparotomy for the RPLND procedure, i.e. thoracic tumor reduction

Study details
    Testicular Cancer

NCT06593665

Indiana University

15 October 2025

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