Status:
RECRUITING
Intrathecal Morphine Versus Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection.
Lead Sponsor:
Indiana University
Conditions:
Testicular Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE3
Brief Summary
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 disse...
Detailed Description
In this study, investigators aim to compare intravenous methadone combined with standard multimodal analgesia and surgical infiltration of local anesthesia to intrathecal duramorph with standard multi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT06593665
Start Date
September 10 2024
End Date
December 31 2026
Last Update
November 13 2024
Active Locations (2)
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1
Indiana Univeristy
Indianapolis, Indiana, United States, 46202
2
Indiana University Hospital
Indianapolis, Indiana, United States, 46202