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NCT06745388 · ClinicalTrials.gov registry record · Phase 4
Magnesium and Cramping
A Phase 4 study of Postoperative Pain Management and Hysteroscopy, sponsored by Corewell Health East.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06745388: Recruiting Phase 4 study of Postoperative Pain Management and Hysteroscopy, sponsored by Corewell Health East.
NCT06745388 is a Phase 4 study of Postoperative Pain Management and Hysteroscopy that is actively recruiting participants, run by Corewell Health East. The registered enrollment target is 150 participants, above the 119-participant average among 7 other Postoperative Pain Management trials with a reported enrollment target (26% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06745388, a Phase 4 study of Postoperative Pain Management and Hysteroscopy, is actively recruiting participants, sponsored by Corewell Health East.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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 pai
Primary Outcome
Pain will be assessed 1 hour post-operatively using a Visual Analog Score (VAS). Pain is reported on a scale from 0-10; where 0=no cramping, and 10=cramping as bad as can be. A lower score indicates a better outcome.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ketamine
- DRUG Magnesium sulfate
Study Locations (1)
Michigan
- Corewell Health William Beaumont University Hospital - Royal Oak
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-07-29 |
| Est. Completion | 2026-09 |
| Phase | Phase 4 |
What NCT06745388 shows while recruiting
NCT06745388 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 119-participant average among 7 other Postoperative Pain Management trials with a reported enrollment target (26% higher).
The record links to 3 conditions, with Postoperative Pain Management appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06745388 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06745388 about?
NCT06745388 is a clinical study titled "Magnesium and Cramping". 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 ...
What is the current status of trial NCT06745388?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2025-07-29. Estimated completion is 2026-09.
What conditions does trial NCT06745388 study?
This clinical trial studies the following conditions: Postoperative Pain Management, Hysteroscopy, Uterine Cramps.
What interventions are being tested in trial NCT06745388?
The interventions under investigation include: Placebo (DRUG), Ketamine (DRUG), Magnesium sulfate (DRUG).
Who is sponsoring clinical trial NCT06745388?
This trial is sponsored by Corewell Health East, which has 106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06745388 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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