Intrathecal Morphine Versus Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection.

Launched by INDIANA UNIVERSITY · Sep 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two methods of pain management for men undergoing surgery to remove lymph nodes due to primary testicular cancer. The researchers want to compare the effectiveness of intrathecal morphine (a pain medication delivered directly into the spinal fluid) and intravenous methadone (a medication given through an IV) in managing pain after surgery. The goal is to see which option provides better relief at different times after the operation.

To participate in this trial, men aged 18 to 80 who are having their first surgery for testicular cancer, or surgery after chemotherapy, may be eligible. However, those who have certain medical conditions, allergies to the study medications, or a history of substance abuse in the past six months cannot join. Participants can expect to receive one of the two pain management treatments and will be monitored for their pain levels after surgery. This study is currently recruiting participants at IU Health AAHC, and understanding the outcomes could help improve pain control for future patients.

Gender

MALE

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 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