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NCT Number: NCT06593665

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Indiana Univeristy, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

Primary outcomes

  1. IV morphine equivalent (MME)

    Time frame: First 24 hours postoperative

    Cumulative Milligrams of morphine equivalent (MME) consumption

Secondary outcomes

  1. Opioid consumption

    Time frame: 1 hour after arrival time to post anesthesia care unit

    Opioid consumption in morphine equivalent (MME)

  2. Opioid consumption

    Time frame: 12 hours after arrival time to post anesthesia care unit

    Opioid consumption in morphine equivalent (MME)

  3. Opioid consumption

    Time frame: 24 hours after arrival time to post anesthesia care unit

    Opioid consumption in morphine equivalent (MME)

  4. Opioid side effect-Nausea

    Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study

    Incidence of opioid side effects-nausea

  5. 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-vomiting

  6. Opioid side effects-Pruritis

    Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study

    Incidence of opioid side effects-pruritis

  7. Adverse Events

    Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study

    Incidence of adverse events

  8. Opioid side effects-Respiratory Depression

    Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study

    Incidence of opioid side effects-respiratory depression

  9. Pain Scores

    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

  10. Pain Scores

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Angie Plummer

CONTACT

[email protected]

3179447293

Lyla S Farlow

CONTACT

[email protected]

3179489804

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Acronym: RPLND

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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