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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Testicular Cancer
• Intervention / Treatment: Drug: Inrathecal Morphine; Drug: Intravenous Methadone

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.

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Lyla S Farlow; Phone Number: 3179489804; Email: lychrist@iu.edu
• Study Contact Backup: Name: Angie Plummer; Phone Number: 3179447293; Email: plummera@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Hospital
      • Contact: Phone Number: 3179489804; Email: lychrist@iupui.edu
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana Univeristy
      • Contact: Angie Plummer, LPN; Phone Number: 317-944-7239; Email: plummera@iupui.edu
      • Contact: Lyla Farlow, LPN; Phone Number: 317-984-9804; Email: lychrist@iupui.edu
      • Principal Investigator: Gulraj S Chawla, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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)
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)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IV morphine equivalent (MME)	Cumulative Milligrams of morphine equivalent (MME) consumption	First 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	Opioid consumption in morphine equivalent (MME)	1 hour after arrival time to post anesthesia care unit
Opioid consumption	Opioid consumption in morphine equivalent (MME)	12 hours after arrival time to post anesthesia care unit
Opioid consumption	Opioid consumption in morphine equivalent (MME)	24 hours after arrival time to post anesthesia care unit
Opioid side effect-Nausea	Incidence of opioid side effects-nausea	after arrival time to post anesthesia care unit until 24 hours/completion of study
Opioid side effects-Vomiting	Incidence of opioid side effects-vomiting	after arrival time to post anesthesia care unit until 24 hours/completion of study
Opioid side effects-Pruritis	Incidence of opioid side effects-pruritis	after arrival time to post anesthesia care unit until 24 hours/completion of study
Adverse Events	Incidence of adverse events	after arrival time to post anesthesia care unit until 24 hours/completion of study
Opioid side effects-Respiratory Depression	Incidence of opioid side effects-respiratory depression	after arrival time to post anesthesia care unit until 24 hours/completion of study
Pain Scores	Visual Analog Scale (VAS) pain score On a scale of 1 to 10 (increments of 1 unit), 1 being no pain at all, 10 being the most pain the patient has ever experienced	24 hours after arrival time to post anesthesia care unit
Pain Scores	Visual Analog Scale (VAS) pain score On a scale of 1 to 10 (increments of 1 unit), 1 being no pain at all, 10 being the most pain the patient has ever experienced	12 hours after arrival time to post anesthesia care unit

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Gulraj S Chawla, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Male Urogenital Diseases; Endocrine Gland Neoplasms; Gonadal Disorders; Testicular Diseases; Testicular Neoplasms; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Morphine; Methadone
• Other Study ID Numbers: 22103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No