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

NCT06593665 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 22103
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• IV morphine equivalent (MME)

  Cumulative Milligrams of morphine equivalent (MME) consumption

  First 24 hours postoperative

Secondary Outcomes (10)

• Opioid consumption

  1 hour after arrival time to post anesthesia care unit

• Opioid consumption

  12 hours after arrival time to post anesthesia care unit

• Opioid consumption

  24 hours after arrival time to post anesthesia care unit

• Opioid side effect-Nausea

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

• Opioid side effects-Vomiting

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

Study Arms (2)

Intrathecal Morphine

OTHER

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: Inrathecal Morphine

Intravenous Methadone

OTHER

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)

Drug: Intravenous Methadone

Interventions

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)

Intravenous Methadone

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)

Intrathecal Morphine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

Indiana Univeristy

Indianapolis, Indiana, 46202, United States

RECRUITING

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Testicular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Officials

• Gulraj S Chawla, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lyla S Farlow

CONTACT

3179489804; lychrist@iu.edu

Angie Plummer

CONTACT

3179447293; plummera@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The primary investigator or his/her designee will inform the anesthesiology team caring for each subject of the arm of the study they are in for each case. Subjects and research staff doing post-operative assessments will be blinded to the randomization.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dept. of Anesthesiology, Asst. Professor

Model Details: A total of 142 subjects will be randomized by a computer program into two groups. 1. Intrathecal preservative free morphine (duramorph) 200mcg with 7.5 mg of hyperbaric bupivacaine placed by a spinal needle prior to induction of general anesthesia (n=71) 2. Intravenous methadone dose at 0.2mg/kg Ideal Body weight up to a maximum dose of 20 mg, rounded to the nearest milligram, for all patients given during the induction of general anesthesia (n=71)

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2025-11

Locations

US (2)