Magnesium Therapy for Postoperative Pain

Overseen By Alex Nighswander

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: Av block, Renal insufficiency, Heart failure, Bradycardia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Participants are being asked to participate in this research study because they have elected to undergo periacetabular osteotomy (PAO). This research study is looking at if using IV magnesium during surgery can help to reduce pain after surgery.

Who Is on the Research Team?

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.

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?

Group I: IV Magnesium Sulfate adjuvant group Experimental Treatment 1 Intervention

Participants in this group will receive standard-of-care procedures intraoperatively and postoperatively along with IV magnesium sulfate for pain control.

Group II: Control group Active Control 1 Intervention

Participants in this group will receive standard-of-care procedures intraoperatively and post-operatively for pain control.

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+