Randomized prospective study comparing intrathecal morphine vs intravenous methadone for postoperative analgesia following retroperitoneal lymph node dissection (RPLND)
G
Gulraj Singh Chawla
Primary Investigator
Enrolling By Invitation
18-80 years
Male
Phase
N/A
142 participants needed
1 Location
Brief description of study
What is the purpose of this study?
At Indiana University Adult Academic Health Center (AAHC), both intrathecal morphine and intravenous methadone are the standard of care for pain management in patients undergoing retroperitoneal lymph node dissections for primary testicular cancer, and both have had great success. In this study, we propose to compare their analgesic effectiveness at different post-operative time intervals.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
Participants will be randomized (by chance, like flipping a coin) into one of the two treatment groups:
- Group 1 will receive an intrathecal (IT) injection (an injection into the spine) in which a small dose of Duramorph (morphine, a pain medication) and Bupivacaine (a numbing medication) will be placed into the spinal fluid prior to going to sleep for their procedure.
- Group 2 will receive Intravenous (in the vein) Methadone (a pain medication).
- Those randomized to the intravenous methadone (IVM) arm will be induced with general anesthesia in the operating room. The patient will receive the intravenous methadone. The patient will receive the intravenous methadone prior to skin incision. The methadone will be given prior to skin incision.
- Participants will receive 1 gram of Tylenol before your procedure no matter which group they are in. This is standard care for the RPLND procedure and will be administered whether or not they choose to participate in the study.
- After patient's procedure, research staff will record information about recovery and hospital stay. These assessments will be performed at regular intervals for 24 hours after the procedure.
- Participants will be in this study from the time of enrollment through about 24 hours after surgery has ended.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Testicular Cancer
-
Age: Between 18 Years - 80 Years
-
Gender: Male
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 (See Appendix)
• Age 18 to 80 years; Male
• BMI < 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
• 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 (See Appendix)
• Age 18 to 80 years; Male
• BMI < 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
Updated on
05 Nov 2024.
Study ID: ANES-IIR-RPLND, 22103
Please visit our main page to search for other studies you may be interested in.
If you need help finding a study or have any questions, please contact us at inhealth@iu.edu
