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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06593665
Phase
PHASE3
Status
Recruiting
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Conditions

  • Testicular Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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)

Study Details

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.

Key Dates

Start date
Sep 10, 2024
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
142 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Intrathecal 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)
  • Other: 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 Measure

IV morphine equivalent (MME) [ Time Frame: First 24 hours postoperative ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Indiana UniveristyIndianapolisIndiana46202
Lyla Farlow, LPN
[email protected]
317-984-9804
Angie Plummer, LPN
[email protected]
317-944-7239
Gulraj S Chawla, MD (PRINCIPAL_INVESTIGATOR)
Indiana University HospitalIndianapolisIndiana46202

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