Intrathecal Morphine Versus Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection.
Key facts
- Who runs it
- Indiana University
- Where
- Indianapolis, United StatesSee the 2 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 142 people, planned
- Started
- 10 Sept 2024
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- Inrathecal Morphine
- Intravenous Methadone
- Record updated
- 13 February 2026
Who can take part
- Age
- 18 years to 80 years
- Sex
- Men only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patient staying intubated after surgery
- 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
- 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
- Any contraindication for neuraxial analgesia
- Patient on home methadone at any dose
- Patient (home dose) taking more than 30mg PO morphine equivalent (PME) per day
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in United States
- Indiana UniveristyIndianapolis, United StatesContact: Lyla Farlow, LPNTaking people
- Indiana University HospitalIndianapolis, United StatesContact: Lyla S FarlowTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Intrathecal MorphineOther group
Intrathecal preservative free morphine (duramorph) 200 mcg with 7.5mg of hyperbaric bupivacaine placed by a spinal needle prior to induction of general anesthesia (n=71)
Treatment: Inrathecal Morphine
- Intravenous MethadoneOther group
Intravenous methadone dosed at 0.2 mg/kg Ideal Body weight up to a maximum dose of 20mg, rounded to the nearest milligram, for all patients given during the induction of general anesthesia (n=71)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized Prospective Study Comparing Intrathecal Morphine vs Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection (RPLND)
- Fit questions
- Built from NCT06593665, who can take part
- Record updated
- 13 February 2026