Malignant Female Reproductive System Neoplasm
Conditions
Brief summary
This phase IV trial compares methadone versus hydromorphone given in the fluid-filled space between the thin layers of tissue that cover the brain and spinal cord (intrathecal) for postoperative pain relief in patients with gynecologic cancer undergo surgery. Methadone binds to opioid receptors in the central nervous system and is a long-acting opioid pain medication. Intrathecal hydromorphone works by changing the way the brain and nervous system respond to pain and is similar to an epidural. This trial may help researchers determine if methadone works as well as intrathecal hydromorphone for pain relief after surgery in patients with gynecologic cancer.
Detailed description
PRIMARY OBJECTIVE: I. To determine whether intravenous methadone can provide comparable analgesia to an intrathecal injection of hydromorphone. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive methadone intravenously (IV) during induction of general anesthesia for standard of care (SOC) surgery. ARM II: Patients receive hydromorphone intrathecally (IT) prior to induction of general anesthesia for SOC surgery. After completion of study intervention, patients are followed up at 1 month.
Interventions
DRUGHydromorphone
Given IT
DRUGMethadone
Given IV
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Undergoing surgery with a laparotomy for gynecologic malignancy * Planned inpatient admission greater than 24 hours
Exclusion criteria
* Chronic pain requiring greater than 20 morphine milligram equivalents of opioid medications as an outpatient * Prolonged corrected QT interval (QTc) \> 500ms * Chronic kidney disease with estimated glomerular filtration rate (eGFR) \< 30 milliliters per minute (mL/min) * Documented cirrhosis * Preoperative platelets (PLT) \< 100 * Preoperative international normalized ratio (INR) \> 1.1 * Inappropriate cessation of anticoagulation medications prior to surgery * Intolerance to hydromorphone or methadone * Contraindication to administration of liposomal bupivacaine * Subsequent surgeries after index surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in pain scores | Baseline, upon leaving post-anesthesia care unit (PACU), and at 4, 8, and 12 hours, up to 24 hours postoperatively | Will be assessed per group \[intravenous (IV) methadone or intrathecal (IT) hydromorphone\] by patient-reported pain on a scale of 0-10 where 0=no pain and 10=worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphine milligram equivalents | Up to 24 hours postoperatively | Will be assessed by the number of morphine milligram equivalents utilized for the first 24 hours postoperatively. |
| Incidence of itching | Up to 24 hours postoperatively | Will be assessed by the number of patients patient-reported itching on follow-up visits. |
| Incidence of respiratory depression | Up to 24 hours postoperatively | Will be assessed by the number of patients who experience incidents of respiratory depression, defined breathing less frequently as a result of opioid administration. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
CONTACTKaren Ishitani, R.N.
PRINCIPAL_INVESTIGATORSean C. Dowdy, M.D.
Mayo Clinic in Rochester
Outcome results
None listed