Malignant Female Reproductive System NeoplasmPhase 4NCT06525740
Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery
A Phase 4 study testing Hydromorphone, Methadone and Questionnaire Administration in people with Malignant Female Reproductive System Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Malignant Female Reproductive System Neoplasm
- What is being tested?
- Hydromorphone, Methadone and Questionnaire Administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2024to 1 Sep 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Undergoing surgery with a laparotomy for gynecologic malignancy
- Planned inpatient admission greater than 24 hours
Who cannot join
- 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
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- Inappropriate cessation of anticoagulation medications prior to surgery
- Intolerance to hydromorphone or methadone
- Contraindication to administration of liposomal bupivacaine
- Subsequent surgeries after index surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Karen Ishitani, RN, 507-538-5355, Ishitani.Karen@mayo.edu
About this study
Official title: Methadone Versus Intrathecal Hydromorphone for Postoperative Analgesia in Patients Undergoing Surgery for Gynecologic Malignancy Via Midline Laparotomy Receiving Liposomal Bupivacaine
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Being tested
- Hydromorphone, Methadone, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
Also called (-)-Hydromorphone, Dihydromorphinone, Hydromorphon
Given IT
MethadoneDrug
Given IV
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (methadone) | Experimental | Patients receive methadone IV during induction of general anesthesia for SOC surgery. Receives: Drug: Methadone; Other: Questionnaire Administration |
| Arm II (hydromorphone) | Experimental | Patients receive hydromorphone IT prior to induction of general anesthesia for SOC surgery. Receives: Drug: Hydromorphone; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, upon leaving post-anesthesia care unit (PACU), and at 4, 8, and 12 hours, up to 24 hours postoperatively
Secondary outcomes (3)
Morphine milligram equivalents
Will be assessed by the number of morphine milligram equivalents utilized for the first 24 hours postoperatively.
Measured: Up to 24 hours postoperatively
Incidence of itching
Will be assessed by the number of patients patient-reported itching on follow-up visits.
Measured: Up to 24 hours postoperatively
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.
Measured: Up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start3 Sep 2024
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Female Reproductive System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean C Dowdy, MD, Mayo Clinic
- Investigators
- Sean C. Dowdy, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525740
- Sponsor's protocol ID
- 24-001383
- Other IDs
- NCI-2024-06145, 24-001383
- Status last verified
- Feb 2026
- First submitted
- 24 Jul 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methadone Versus Intrathecal Hydromorphone for Postoperative Analgesia in Patients Undergoing Surgery for Gynecologic Malignancy Via Midline Laparotomy Receiving Liposomal Bupivacaine
- ClinicalTrials.gov ID
- NCT06525740
- Acronym / sponsor ID
- 24-001383
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (methadone) | Experimental | Drug: Methadone, Other: Questionnaire AdministrationPatients receive methadone IV during induction of general anesthesia for SOC surgery. |
| Arm II (hydromorphone) | Experimental | Drug: Hydromorphone, Other: Questionnaire AdministrationPatients receive hydromorphone IT prior to induction of general anesthesia for SOC surgery. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing surgery with a laparotomy for gynecologic malignancy
- Planned inpatient admission greater than 24 hours
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydromorphoneAlso: (-)-Hydromorphone, Dihydromorphinone, HydromorphonGiven IT | Drug | Arm II (hydromorphone) |
| MethadoneGiven IV | Drug | Arm I (methadone) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (methadone), Arm II (hydromorphone) |
Primary outcome
Difference in pain scores
Time frame: Baseline, upon leaving post-anesthesia care unit (PACU), and at 4, 8, and 12 hours, up to 24 hours postoperatively
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.
3 secondary outcomes
Morphine milligram equivalents
Time frame: Up to 24 hours postoperatively
Incidence of itching
Time frame: Up to 24 hours postoperatively
Incidence of respiratory depression
Time frame: Up to 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sean C. Dowdy, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydromorphone, Methadone and Questionnaire Administration in people with Malignant Female Reproductive System Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in pain scores (time frame: Baseline, upon leaving post-anesthesia care unit (PACU), and at 4, 8, and 12 hours, up to 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.