Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073, United States
Location status: Recruiting
Location contact
Pamela Sloan, RN, BSN
CONTACT
Ray Soto, MD
CONTACT
NCT Number: NCT06745388
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 4
Royal Oak, Michigan, 48073, United States
Location status: Recruiting
Pamela Sloan, RN, BSN
CONTACT
Ray Soto, MD
CONTACT
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 initially contact via phone call 1 week prior to the procedure. If interested in participating, the study will be discussed pre-operatively and consent will be obtained. Baseline data including demographics, gynecological medical and surgical history, social history, allergies, current medications, ASA status, diagnosis, treatment and paucity will be collected.
The participant will be randomized to one of three study arms: IV magnesium, IV push ketamine, or placebo. The participants and evaluators will be blinded to the assigned study arm. The Principal Investigator and Anesthesiologist will not be blinded. All participants will receive standard of care anesthesia care and standard of care for the procedure.
Post-procedure, participants will receive standard of care pain management. Opioid consumption documented in the EMR will be recorded, and pain post-procedure pain will be assessed. Overall pain and cramping pain will be assessed using the Visual Analog Scale (VAS) at 1 hour, 2 hours, and 24 hours post procedure. The 24 hour pain assessment will be completed via phone.
Adverse events will be monitored for 24 hours post operatively.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receive intravenous magnesium intra-operatively
Receive IV push ketamine intra-operatively
Receives no additional medication or infusion
Time frame: 1 hour post-operatively
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.
Time frame: 2 hours post-operatively
Pain will be assessed 2 hours 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.
Time frame: 24 hours post-operatively
Pain will be assessed 24 hours post-operatively using a Visual Analog Score (VAS). Pain is reported using a scale from 0-10; where 0=no cramping, and10=cramping as bad as can be. A lower score indicates a better outcome.
Time frame: 1 hour post-operatively
Overall pain will be assessed 1 hour post-operatively using a 100-point Visual Analog Score (VAS). Pain is reported on a scale from 0-100; where 0=no pain, and 100=pain as bad as can be. A lower score indicates a better outcome.
Time frame: 2 hours post-operatively
Overall pain will be assessed 2 hours post-operatively using a 100-point Visual Analog Score (VAS). Pain is reported on a scale from 0-100; where 0=no pain, and 100=pain as bad as can be. A lower score indicates a better outcome.
Time frame: 24 hours post-operatively
Overall pain will be assessed 24 hours post-operatively using a 100-point Visual Analog Score (VAS). Pain is reported on a scale from 0-100; where 0=no pain, and 100=pain as bad as can be. A lower score indicates a better outcome.
Time frame: 24 hours post-operatively
Opioid consumption will be recorded in morphine milligram equivalents (MME). The total MME for all patients for each intervention arm. A lower number indicates a better outcome as fewer opioids were consumed for pain management post-procedure.
Contact information is provided by the study sponsor or research team.
Pamela Sloan, RN, BSN
CONTACT
Ray Soto, MD
CONTACT
Corewell Health East
Other
Evaluating the Impacts of Intravenous Magnesium Sulfate and Ketamine on Cramping Pain and Total Opioid Consumption Following Hysteroscopy: A Prospective, Randomized Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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