RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-10
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06593665

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients undergoing a virgin (chemotherapy has not been used) or post- chemotherapy retroperitoneal lymph node dissection for primary testicular cancer at IU Health AAHC
  2. * ASA Class 1, 2, 3
  3. * Age 18 to 80 years; Male
  4. * BMI less than 50kg/m2
  1. * Any contraindication for neuraxial analgesia
  2. * Patient on home methadone at any dose
  3. * Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
  4. * Known true allergy to the study medications (morphine, bupivacaine, acetaminophen, methadone)
  5. * Any history of substance abuse in the past 6 months which would include heroin or any other illegal street drugs
  6. * End stage liver disease, end stage renal disease
  7. * Patient staying intubated after surgery
  8. * Patient (home dose) taking more than 30mg PO morphine equivalent (PME) per day
  9. * 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

Contacts and Locations

Study Contact

Lyla S Farlow
CONTACT
3179489804
lychrist@iu.edu
Angie Plummer
CONTACT
3179447293
plummera@iu.edu

Principal Investigator

Gulraj S Chawla, MD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

Indiana Univeristy
Indianapolis, Indiana, 46202
United States
Indiana University Hospital
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Gulraj S Chawla, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-10
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-09-10
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Testicular Cancer