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Opioid

Morphine vs Methadone for Post-Surgery Pain in Testicular Cancer (RPLND Trial)

N/A

Waitlist Available

Led By Gulraj S Chawla, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 80 years; Male

Patients undergoing a virgin (chemotherapy has not been used) or post-chemotherapy retroperitoneal lymph node dissection for primary testicular cancer at IU Health AAHC

Must not have

Any contraindication for neuraxial analgesia

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first 24 hours postoperative

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two common pain management methods, intrathecal morphine and intravenous methadone, for patients having surgery for testicular cancer. Researchers will see which method works better at different

Who is the study for?

This trial is for patients with primary testicular cancer who are undergoing retroperitoneal lymph node dissection. Specific eligibility criteria details were not provided, so interested individuals should inquire further to determine if they qualify.

What is being tested?

The study aims to compare the pain management effectiveness of intrathecal morphine and intravenous methadone in postoperative care after surgery for testicular cancer. It's a randomization study, meaning patients will be randomly assigned one of the two standard treatments.

What are the potential side effects?

While specific side effects are not listed, both intrathecal morphine and intravenous methadone can generally cause nausea, vomiting, itching, respiratory depression, and sedation among other potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man aged between 18 and 80.

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I am having my first or a follow-up lymph node surgery for testicular cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have spinal or epidural pain relief.

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I have had surgery with an incision different from the usual for my condition.

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I am currently taking methadone at home.

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I do not have end stage liver or kidney disease.

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I take more than 30mg of pain medication daily.

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I remained on a breathing machine after surgery.

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I am allergic to morphine, bupivacaine, acetaminophen, or methadone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first 24 hours postoperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first 24 hours postoperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and first 24 hours postoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

IV morphine equivalent (MME)

Secondary study objectives

Adverse Events

Opioid consumption

Opioid side effect-Nausea

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Intravenous MethadoneExperimental Treatment1 Intervention

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)

Group II: Intrathecal MorphineExperimental Treatment1 Intervention

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)

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

1,034 Previous Clinical Trials

1,119,010 Total Patients Enrolled

1 Trials studying Testicular Cancer

150 Patients Enrolled for Testicular Cancer

Gulraj S Chawla, MDPrincipal InvestigatorIndiana University

~95 spots leftby Dec 2026

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