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

Last updated: November 11, 2024
Sponsor: Indiana University
Overall Status: Active - Recruiting

Phase

3

Condition

Testicular Cancer

Urologic Cancer

Treatment

Intravenous Methadone

Inrathecal Morphine

Intravenous Methadone

Clinical Study ID

NCT06593665
22103
  • Ages 18-80
  • Male

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients undergoing a virgin (chemotherapy has not been used) or post- chemotherapyretroperitoneal lymph node dissection for primary testicular cancer at IU HealthAAHC

  • ASA Class 1, 2, 3

  • Age 18 to 80 years; Male

  • BMI less than 50kg/m2

Exclusion

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 theinvestigators, 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 orany 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 incisioncompared to the standard laparotomy for the RPLND procedure, i.e. thoracic tumorreduction

Study Design

Total Participants: 142
Treatment Group(s): 4
Primary Treatment: Intravenous Methadone
Phase: 3
Study Start date:
September 10, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Indiana Univeristy

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Indiana University Hospital

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

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