64 Participants Needed

Magnesium Therapy for Postoperative Pain

EF
AN
Overseen ByAlex Nighswander
Age: Any Age
Sex: Any
Trial Phase: Phase 4
Sponsor: University Hospitals Cleveland Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether IV magnesium (magnesium therapy) during surgery can reduce pain for individuals undergoing periacetabular osteotomy (PAO). Participants will be divided into two groups: one will receive IV magnesium with standard pain management, while the other will receive only standard care. The study seeks participants planning to undergo PAO, with or without an additional hip procedure. It is not suitable for those with certain heart issues, such as AV block, severe kidney problems, or heart failure. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for IV Magnesium Sulfate?

Research shows that IV magnesium sulfate is usually well-tolerated for managing post-surgical pain. Studies have found it can reduce pain and decrease the need for opioids, which are strong painkillers. As a result, patients often feel better and require less medication to manage their pain.

Regarding safety, previous research has not identified significant adverse side effects when using it for pain control. Patients who received magnesium sulfate reported less severe pain both immediately after surgery and the following day.

While IV magnesium sulfate is primarily used for pain control, its application in various surgeries suggests it is safe for most people. Since this trial is in Phase 4, the treatment has undergone extensive study and is likely well-understood in terms of safety. As always, discussing any concerns with a healthcare provider is advisable.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using IV magnesium sulfate for postoperative pain because it offers a unique approach compared to standard pain management options like opioids and NSAIDs. Unlike these typical treatments, magnesium sulfate works by blocking specific receptors in the nervous system that are involved in pain transmission, potentially leading to effective pain relief with fewer side effects. Additionally, magnesium sulfate is administered intravenously, allowing for precise control over dosage and rapid action, which can be particularly beneficial in a surgical setting. This method has the potential to reduce reliance on opioids, addressing concerns about addiction and side effects associated with traditional pain medications.

What evidence suggests that IV magnesium sulfate might be an effective treatment for postoperative pain?

Research shows that IV magnesium sulfate, which participants in this trial may receive, can help reduce post-surgical pain. Studies have found that it lowers pain levels and reduces the need for strong painkillers like opioids after surgeries, including abdominal and spine operations. One study found that magnesium sulfate reduced pain six hours after surgery and decreased morphine use. Another study noted that patients required fewer pain medications during and after their surgeries when they received magnesium sulfate. Overall, magnesium sulfate has shown promise in easing post-surgical pain and reducing the need for painkillers.12678

Who Is on the Research Team?

RW

Robert Wetzel, MD

Principal Investigator

University Hospitals

Are You a Good Fit for This Trial?

This trial is for patients who are having a specific hip surgery called periacetabular osteotomy, with or without additional hip arthroscopy. Participants must be able to read and understand English. Those with certain heart conditions (like AV block or bradycardia), severe kidney issues, or heart failure cannot join.

Inclusion Criteria

I am having surgery to correct my hip socket with or without additional hip surgery.

Exclusion Criteria

You have a specific type of heart block called 2nd or 3rd degree AV block.
I have severe kidney problems.
I have heart failure.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo periacetabular osteotomy (PAO) and receive either standard-of-care procedures or IV magnesium sulfate for pain control

Intraoperative and immediate postoperative period

Follow-up

Participants are monitored for changes in pain and functional outcomes using VAS, PROMIS, and mHHS scores

1 year
Visits at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • IV Magnesium Sulfate
Trial Overview The study is testing if giving magnesium sulfate through an IV during the surgery can help reduce pain after the operation. It aims to see whether this mineral supplement could serve as an effective addition to postoperative pain management.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: IV Magnesium Sulfate adjuvant groupExperimental Treatment1 Intervention
Group II: Control groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials
348
Recruited
394,000+

Citations

Effect of intravenous magnesium on postoperative pain ...In this study, intravenous magnesium sulfate after abdominal surgeries for 24 h resolved the pain intensity after six hours and reduced morphine dosage.
Review Article Unravelling the analgesic effects of ...Magnesium sulfate administration was linked to reduced postoperative pain and opioid consumption following general abdominal surgery.
The Effect of Intraoperative Intravenous Magnesium ...In these settings, Mg has shown promising sequel in reducing postoperative pain scores, decreasing opioid consumption, and improving overall ...
Effectiveness and impact of intravenous magnesium sulfate in ...Intravenous magnesium sulfate demonstrated significant benefits in reducing postoperative pain and opioid consumption, while also improving verbal response and ...
Investigating the effect of magnesium sulfate administrationIn other studies, the administration of magnesium sulfate resulted in a reduction in the need for analgesics during and after surgery, as well as postoperative ...
Magnesium sulfate for postoperative pain in orthopedic...The most frequently reported primary outcomes were sensory and motor block onset and recovery, as well as duration of analgesia. MgSO4 was shown ...
Magnesium Infusion for Pain Management in Critically Ill ...Magnesium sulfate has also proven to be successful in managing pain before and after surgery. However, this drug has primarily been used for pain control in ...
Influence of Intravenous Magnesium Sulfate Infusion on the ...Patients receiving magnesium sulfate also experienced less severe postoperative pain, both in the PACU and 24 h after surgery. While the ...
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