Comparing intrathecal morphine and intravenous methadone for pain relief after surgery for testicular cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of intrathecal morphine versus intravenous methadone for managing postoperative pain in patients undergoing retroperitoneal lymph node dissection for primary testicular cancer. It is a single-blinded, prospective, randomized control trial that will assess pain relief and opioid consumption in the first 24 hours after surgery. Participants will receive either intrathecal morphine or intravenous methadone, along with standard multimodal analgesia and local anesthesia infiltration. The goal is to determine which method provides better analgesia and reduces opioid use.

Why it matters

Who can join: the full rules

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

Where it's running

• Indiana Univeristy
  Indianapolis, Indiana, United States Recruiting
• Indiana University Hospital
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Gulraj S Chawla, MD — Indiana University
• Study coordinator: Lyla S Farlow
• Email: lychrist@iu.edu
• Phone: 3179489804

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.