Health TrialsbyHealthPanel

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

ConditionMalignant Female Reproductive System Neoplasm
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Hydromorphone

    Drug

    Given IT

  • Methadone

    Drug

    Given IV

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Arm I (methadone)Experimental treatment 2 interventions
Group B: Arm II (hydromorphone)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Difference in pain scores

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.

Time frame
Baseline, upon leaving post-anesthesia care unit (PACU), and at 4, 8, and 12 hours, up to 24 hours postoperatively

Secondary outcomes

1

Morphine milligram equivalents

Will be assessed by the number of morphine milligram equivalents utilized for the first 24 hours postoperatively.

Time frame
Up to 24 hours postoperatively
2

Incidence of itching

Will be assessed by the number of patients patient-reported itching on follow-up visits.

Time frame
Up to 24 hours postoperatively
3

Incidence of respiratory depression

Will be assessed by the number of patients who experience incidents of respiratory depression, defined breathing less frequently as a result of opioid administration.

Time frame
Up to 24 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
Apply now