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Magnesium Therapy for Postoperative Pain

Phase 4

Waitlist Available

Led By Robert Wetzel, MD

Research Sponsored by University Hospitals Cleveland Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing periacetabular osteotomy with or without adjuvant hip arthroscopy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks, 6 weeks, 3 months, 6 months, 1 year

Awards & highlights

Study Summary

This trial looks at if IV magnesium can reduce post-surgery pain after periacetabular osteotomy (PAO). Patients are needed to participate. #PAO #Magnesium #Research

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Magnesium sulfate may cause side effects such as flushing, sweating, lowered blood pressure, confusion, muscle weakness, and in rare cases abnormal heart rhythms especially in those with kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks, 6 weeks, 3 months, 6 months, 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks, 6 weeks, 3 months, 6 months, 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks, 6 weeks, 3 months, 6 months, 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in number of narcotic medications consumed as measured by the medical record review

Change in pain as measured by the Visual Analog Scale (VAS)

Secondary outcome measures

Change in PROMIS scores

Change in modified Harris Hip Scores (mHHS)

Side effects data

From 2012 Phase 4 trial • 200 Patients • NCT01342510

30%

Pain with injection of propofol

100%

80%

60%

40%

20%

Study treatment Arm

Lidocaine/Magnesium

Control

Lidocaine

Magnesium

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IV Magnesium Sulfate adjuvant groupExperimental Treatment1 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 groupActive Control1 Intervention

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

0 / 1Eligibility criteria met