Clinical trial NCT06525740: Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery
Official title: Methadone Versus Intrathecal Hydromorphone for Postoperative Analgesia in Patients Undergoing Surgery for Gynecologic Malignancy Via Midline Laparotomy Receiving Liposomal Bupivacaine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Malignant Female Reproductive System Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 140
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in pain scores
timeFrame: Baseline, upon leaving post-anesthesia care unit (PACU), and at 4, 8, and 12 hours, up to 24 hours postoperatively
Secondary outcomes:
measure: Morphine milligram equivalents
timeFrame: Up to 24 hours postoperatively
measure: Incidence of itching
timeFrame: Up to 24 hours postoperatively
measure: Incidence of respiratory depression
timeFrame: Up to 24 hours postoperatively
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Sean C. Dowdy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: