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Recruiting NCT06593665

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

Phase III Interventional Testicular Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inrathecal Morphine, Intravenous Methadone.
Who it may be relevant to
Registry conditions: Testicular Cancer. Basic parameters: 18 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Detailed 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.

Interventions

  • Drug Inrathecal 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)
  • Drug Intravenous 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)

Primary outcome measures

  • IV morphine equivalent (MME) [Time frame: First 24 hours postoperative]
Secondary outcome measures (10)
  • Opioid consumption [Time frame: 1 hour after arrival time to post anesthesia care unit]
  • Opioid consumption [Time frame: 12 hours after arrival time to post anesthesia care unit]
  • Opioid consumption [Time frame: 24 hours after arrival time to post anesthesia care unit]
  • Opioid side effect-Nausea [Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study]
  • Opioid side effects-Vomiting [Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study]
  • Opioid side effects-Pruritis [Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study]
  • Adverse Events [Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study]
  • Opioid side effects-Respiratory Depression [Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study]
  • Pain Scores [Time frame: 24 hours after arrival time to post anesthesia care unit]
  • Pain Scores [Time frame: 12 hours after arrival time to post anesthesia care unit]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

United States · 2 centers
  • Indiana Univeristy — Indianapolis
  • Indiana University Hospital — Indianapolis

Identifiers

NCT: NCT06593665 · 22103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗