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Trial Title:
Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery
NCT ID:
NCT06525740
Condition:
Malignant Female Reproductive System Neoplasm
Conditions: Official terms:
Genital Neoplasms, Female
Methadone
Hydromorphone
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Hydromorphone
Description:
Given IT
Arm group label:
Arm II (hydromorphone)
Other name:
(-)-Hydromorphone
Other name:
Dihydromorphinone
Other name:
Hydromorphon
Intervention type:
Drug
Intervention name:
Methadone
Description:
Given IV
Arm group label:
Arm I (methadone)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (methadone)
Arm group label:
Arm II (hydromorphone)
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Undergoing surgery with a laparotomy for gynecologic malignancy
- Planned inpatient admission greater than 24 hours
Exclusion Criteria:
- Chronic pain requiring opioid medications as an outpatient
- Prolonged corrected QT interval (QTc) > 480ms
- Chronic kidney disease with estimated glomerular filtration rate (eGFR) < 30
milliliters per minute (mL/min)
- Documented cirrhosis
- Preoperative platelets (PLT) < 75
- Preoperative international normalized ratio (INR) > 1.5
- Inappropriate cessation of anticoagulation medications prior to surgery
- Intolerance to hydromorphone or methadone
- Contraindication to administration of liposomal bupivacaine
- Subsequent surgeries after index surgery
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Karen Ishitani, RN
Phone:
507-538-5355
Email:
Ishitani.Karen@mayo.edu
Contact backup:
Last name:
Sean C. Dowdy, MD.
Start date:
September 3, 2024
Completion date:
September 1, 2029
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06525740
https://www.mayo.edu/research/clinical-trials
