Intrathecal Morphine Versus Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection.
NCT06593665 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142
Last updated 2026-02-13
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.
Conditions
- Testicular Cancer
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)
Sponsors & Collaborators
-
Indiana University
lead OTHER
Principal Investigators
-
Gulraj S Chawla, MD · Indiana University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-10
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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