Randomized Prospective Study Comparing Intrathecal Morphine Vs Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection (RPLND)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 dissections for primary testicular cancer. Investigators plan to compare their analgesic effectiveness at different postoperative time intervals.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Indiana
Indiana Univeristy
RECRUITING
Indianapolis
Indiana University Hospital
RECRUITING
Indianapolis
Contact Information
Primary
Lyla S Farlow
lychrist@iu.edu
3179489804
Backup
Angie Plummer
plummera@iu.edu
3179447293
Time Frame
Start Date: 2024-09-10
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 142
Treatments
Other: Intrathecal Morphine
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)
Other: Intravenous Methadone
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)
Related Therapeutic Areas
Sponsors
Leads: Indiana University