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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• Undergoing surgery with a laparotomy for gynecologic malignancy

• Planned inpatient admission greater than 24 hours

Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Backup
Karen Ishitani, R.N.
Ishitani.Karen@mayo.edu
507-538-5355
Time Frame
Start Date: 2024-09-03
Estimated Completion Date: 2029-09-01
Participants
Target number of participants: 140
Treatments
Experimental: Arm I (methadone)
Patients receive methadone IV during induction of general anesthesia for SOC surgery.
Experimental: Arm II (hydromorphone)
Patients receive hydromorphone IT prior to induction of general anesthesia for SOC surgery.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov