Recruiting
Phase 3

Morphine vs. Methadone

Sponsor:

Indiana University

Code:

NCT06593665

Conditions

Testicular Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Inrathecal Morphine

Intravenous Methadone

Study Details

Brief 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

Study ID

NCT06593665

Start date

Sep 10, 2024

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

142 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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)

Interventions

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)

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 and Locations

Central contacts

Lyla S Farlow

3179489804lychrist@iu.edu

Angie Plummer

3179447293plummera@iu.edu

Locations

Indiana Univeristy

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Lyla Farlow, LPN

317-984-9804lychrist@iupui.edu

Angie Plummer, LPN

317-944-7239plummera@iupui.edu

Principal Investigator:

Gulraj S Chawla, MD

Indiana University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

3179489804lychrist@iupui.edu

More Information

Sponsor

Indiana University

Last update posted

Feb 13, 2026

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-02-13.