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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 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%
0%
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.

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor
317 Previous Clinical Trials
340,193 Total Patients Enrolled
5 Trials studying Postoperative Pain
254 Patients Enrolled for Postoperative Pain
Robert Wetzel, MDPrincipal InvestigatorUniversity Hospitals

Media Library

IV Magnesium Sulfate adjuvant group Clinical Trial Eligibility Overview. Trial Name: NCT05947760 — Phase 4
Postoperative Pain Research Study Groups: IV Magnesium Sulfate adjuvant group, Control group
Postoperative Pain Clinical Trial 2023: IV Magnesium Sulfate adjuvant group Highlights & Side Effects. Trial Name: NCT05947760 — Phase 4
IV Magnesium Sulfate adjuvant group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05947760 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruits still being sought for this experiment?

"Based on the current information available, it appears that this trial is no longer seeking participants. Originally posted in September of 2023 and last updated in July of 2023, there are 505 other clinical studies looking for volunteers at present."

Answered by AI

Who is eligible to partake in this trial?

"Those who wish to take part in this medical study must be between the ages of 14 and 89, suffer from post-operative pain, and meet other criteria. 64 candidates are expected to join the trial."

Answered by AI

What is the potential risk to individuals when utilizing IV Magnesium Sulfate as an adjunct treatment?

"Data suggests that the IV Magnesium Sulfate adjuvant group has a safety rating of 3, as this is an approved treatment in Phase 4 trials."

Answered by AI

Is this clinical research open to participants of advanced age?

"For this trial, participants must be aged 14 to 89 years old. Of these individuals, 68 are underage and 400 are over the age of retirement."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Magnesium as an Adjuvant Agent for Postoperative Pain
Robert Wetzel, MD 2024. "Magnesium as an Adjuvant Agent for Postoperative Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05947760.
~43 spots leftby Apr 2025
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