Comparing intrathecal morphine and intravenous methadone for pain relief after surgery for testicular cancer
Randomized Prospective Study Comparing Intrathecal Morphine vs Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection (RPLND)
This study is testing whether pain relief after testicular cancer surgery is better with intrathecal morphine or intravenous methadone to help patients feel more comfortable and use less medication.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Indiana University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Indianapolis, Indiana and 1 other locations) |
| Trial ID | NCT06593665 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are male patients aged 18 to 80 years undergoing their first retroperitoneal lymph node dissection for primary testicular cancer.
Not a fit: Patients with contraindications for neuraxial analgesia or those with a history of substance abuse in the past 6 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing surgery for testicular cancer.
How similar studies have performed: Previous studies have shown varying success with similar approaches, but this specific comparison of intrathecal morphine and intravenous methadone is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Indianapolis, Indiana and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.