Testicular Cancer
Conditions
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 dissections for primary testicular cancer. Investigators plan to compare their analgesic effectiveness at different postoperative time intervals.
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 multimodal analgesia and surgical infiltration of local anesthesia. In this single blinded prospective randomized control trial, investigators hypothesize that intravenous methadone will provide a significant reduction in patient opioid consumption when compared to intrathecal opioid analgesia in the first 24 hours in patients who undergo PC/RPLND.
Interventions
DRUGInrathecal 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)
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)
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Masking description
The primary investigator or his/her designee will inform the anesthesiology team caring for each subject of the arm of the study they are in for each case. Subjects and research staff doing post-operative assessments will be blinded to the randomization.
Intervention model description
A total of 142 subjects will be randomized by a computer program into two groups. 1. Intrathecal preservative free morphine (duramorph) 200mcg with 7.5 mg of hyperbaric bupivacaine placed by a spinal needle prior to induction of general anesthesia (n=71) 2. Intravenous methadone dose at 0.2mg/kg Ideal Body weight up to a maximum dose of 20 mg, rounded to the nearest milligram, for all patients given during the induction of general anesthesia (n=71)
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IV morphine equivalent (MME) | First 24 hours postoperative | Cumulative Milligrams of morphine equivalent (MME) consumption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | 1 hour after arrival time to post anesthesia care unit | Opioid consumption in morphine equivalent (MME) |
| Opioid side effect-Nausea | after arrival time to post anesthesia care unit until 24 hours/completion of study | Incidence of opioid side effects-nausea |
| Opioid side effects-Vomiting | after arrival time to post anesthesia care unit until 24 hours/completion of study | Incidence of opioid side effects-vomiting |
| Opioid side effects-Pruritis | after arrival time to post anesthesia care unit until 24 hours/completion of study | Incidence of opioid side effects-pruritis |
| Adverse Events | after arrival time to post anesthesia care unit until 24 hours/completion of study | Incidence of adverse events |
| Opioid side effects-Respiratory Depression | after arrival time to post anesthesia care unit until 24 hours/completion of study | Incidence of opioid side effects-respiratory depression |
| Pain Scores | 24 hours after arrival time to post anesthesia care unit | Visual Analog Scale (VAS) pain score On a scale of 1 to 10 (increments of 1 unit), 1 being no pain at all, 10 being the most pain the patient has ever experienced |
Countries
United States
Contacts
CONTACTLyla S Farlow
CONTACTAngie Plummer
PRINCIPAL_INVESTIGATORGulraj S Chawla, MD
Indiana University
Outcome results
None listed