Magnesium and Cramping

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCorewell Health East

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Magnesium sulfate

    Drug

    Receive intravenous magnesium intra-operatively

  • Ketamine

    Drug

    Receive IV push ketamine intra-operatively

  • Placebo

    Drug

    Receives no additional medication or infusion

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Magnesium, IVExperimental treatment 1 intervention
Group B: Ketamine, IVExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cramping Pain Following Hysteroscopy (1 hr post-operative)

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
1 hour post-operatively
2

Cramping Pain Following Hysteroscopy (2 hr post-operative)

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
2 hours post-operatively
3

Cramping Pain Following Hysteroscopy (24 hour post-operative)

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
24 hours post-operatively
4

Overall Pain following hysteroscopy (1 hr post-operative)

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
1 hour post-operatively

Secondary outcomes

1

Opioid consumption Following Hysteroscopy

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.

Time frame
24 hours post-operatively

Other outcomes

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