Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

Undergoing surgery with a laparotomy for gynecologic malignancy

Planned inpatient admission greater than 24 hours

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Hydromorphone
  • Methadone
  • Questionnaire Administration

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators