RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Methadone Versus Intrathecal Hydromorphone for Postoperative Analgesia in Patients Undergoing Surgery for Gynecologic Malignancy Via Midline Laparotomy Receiving Liposomal Bupivacaine

Quick Facts

Study Start:2024-09-03
Study Completion:2029-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06525740

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Undergoing surgery with a laparotomy for gynecologic malignancy
  2. * Planned inpatient admission greater than 24 hours
  1. * Chronic pain requiring opioid medications as an outpatient
  2. * Prolonged corrected QT interval (QTc) \> 480ms
  3. * Chronic kidney disease with estimated glomerular filtration rate (eGFR) \< 30 milliliters per minute (mL/min)
  4. * Documented cirrhosis
  5. * Preoperative platelets (PLT) \< 75
  6. * Preoperative international normalized ratio (INR) \> 1.5
  7. * Inappropriate cessation of anticoagulation medications prior to surgery
  8. * Intolerance to hydromorphone or methadone
  9. * Contraindication to administration of liposomal bupivacaine
  10. * Subsequent surgeries after index surgery

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu
Karen Ishitani, R.N.
CONTACT
507-538-5355
Ishitani.Karen@mayo.edu

Principal Investigator

Sean C. Dowdy, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Sean C. Dowdy, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-03
Study Completion Date2029-09-01

Study Record Updates

Study Start Date2024-09-03
Study Completion Date2029-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Malignant Female Reproductive System Neoplasm