| NCT ID | NCT06745388 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Corewell Health East |
| Condition | Uterine Cramps |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-07-29 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 150 participants in total. It began in 2025-07-29 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Hysteroscopy (an exam to look inside the uterus) is one of the most frequently performed procedures for patients with cervical or uterine disorders. It is the gold standard for evaluating various intrauterine problems, pre-menopausal and post-menopausal abnormal uterine bleeding, as well as being a vital examination modality for infertility work-up. Although hysteroscopy is a minimally invasive procedure, it is still known to be a painful experience that requires effective analgesia (meaning pain reduction) to achieve maximum patient comfort and cooperation. Historically, opioids, particularly fentanyl, have held precedence as the primary agents for providing analgesia following surgery of this type. However, despite their efficacy, these agents come with notable drawbacks, including the potential for serious side effects such as respiratory depression, addiction, and postoperative nausea and vomiting. Both magnesium and ketamine are routinely used to reduce pain following this procedure. Both drugs work on the N-methyl-D-aspartate (NMDA) receptor in the brain to reduce pain, and magnesium has an additional effect in that it can relax smooth muscles. Magnesium has been used successfully to reduce the pain associated with menstrual cramps, which is similar to the pain patients experience after hysteroscopy. A recent study demonstrated the benefits of adding intravenous magnesium with routine anesthesia during hysteroscopy, revealing a significant decrease in postoperative pain and rescue analgesics. However, this study did not compare the effects of magnesium to ketamine, nor did they characterize the nature of the patients' pain. It is unclear if the pain reduction with magnesium comes from its effect on the NMDA receptor or from it's cramp-reduction effect. We seek to establish whether administering IV magnesium, compared to ketamine, can specifically mitigate uterine cramping pain and total opioid consumption in hopes of finding additional safe and effective pain modalities for patients. This is a prospective, randomized trial enrolling participants undergoing an elective hysteroscopy or Dilation and Curettage (D\&C) at Corewell Health William Beaumont University Hospital in Royal Oak. Participants will be randomized to 1 of 3 treatments: Intravenous (IV) Magnesium, IV Push Ketamine, or Placebo. Opioid consumption is recorded via the electronic medical record (EMR), while overall pain and cramping pain will be captured post-procedure in the hospital and 24 hours later via a phone call.
Eligibility Criteria
Inclusion Criteria: * Patients undergoing an elective hysteroscopy or dilation and curettage (D\&C) * American Society of Anesthesiologists (ASA) Physical Status 1 - 3 * Age 18 years or older Exclusion Criteria: * Chronic Pain Patients (taking opioids within one week of procedure) * Psychiatric Disorders (current treatment for anxiety/depression) * Allergies to any of the medications that will be administered * Current use of magnesium, analgesics, antidepressants, anxiolytics, or opioids * ASA Physical Status 4 or above * Developmentally delayed patients that would not be able to verbalize pain scores * Minors (under 18 years of age) * Pregnant women
Contact & Investigator
Ray Soto, MD
PRINCIPAL INVESTIGATOR
Corewell Health East
Frequently Asked Questions
Who can join the NCT06745388 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Uterine Cramps. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06745388 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06745388 currently recruiting?
Yes, NCT06745388 is actively recruiting participants. Contact the research team at roy.soto@corewellhealth.org for enrollment information.
Where is the NCT06745388 trial being conducted?
This trial is being conducted at Royal Oak, United States.
Who is sponsoring the NCT06745388 clinical trial?
NCT06745388 is sponsored by Corewell Health East. The principal investigator is Ray Soto, MD at Corewell Health East. The trial plans to enroll 150 participants.