Intrathecal Morphine Versus Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection.
Recruiting
Phase 3
Interventional Study
Testicular Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 142 (estimated)
- Sponsor
- Indiana University · Other
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About This Trial
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.
Trial Locations
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Eligibility 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 contrain…
Contacts