Magnesium as an Adjuvant Agent for Postoperative Pain

April 17, 2026 updated by: Robert Wetzel, MD, University Hospitals Cleveland Medical Center

Magnesium as an Adjuvant Agent for Postoperative Pain Control Following Periacetabular Osteotomy

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing periacetabular osteotomy with or without adjuvant hip arthroscopy

Exclusion Criteria:

  • illiterate or non-English speaking patients
  • patients with 2nd or 3rd degree AV block
  • patients with severe renal insufficiency
  • patients with heart failure
  • patients with bradycardia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IV Magnesium Sulfate adjuvant group
Participants in this group will receive standard-of-care procedures intraoperatively and postoperatively along with IV magnesium sulfate for pain control.
Drug: IV Magnesium Sulfate
Participants will receive IV Magnesium Sulfate intraoperatively.
No Intervention: Control group
Participants in this group will receive standard-of-care procedures intraoperatively and post-operatively for pain control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain as measured by the Visual Analog Scale (VAS)
Time Frame: Over the first 7 days post operatively, measured every 6 hours
The VAS is a scale from 0-10 with 0 being no pain and 10 being the worst pain ever
Over the first 7 days post operatively, measured every 6 hours
Change in number of narcotic medications consumed as measured by the medical record review
Time Frame: Over the first 7 days post operatively, gathered every 6 hours.
Over the first 7 days post operatively, gathered every 6 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PROMIS scores
Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year
The PROMIS is a 14 item questionnaire is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Scores are typically between 20-80, but may be 0-100.
2 weeks, 6 weeks, 3 months, 6 months, 1 year
Change in modified Harris Hip Scores (mHHS)
Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year
The mHHS is a scoring system for functional outcomes post periactabular osteotomies that has a scale of 0-100, 0 being the lowest functional outcome and 100 being the highest
2 weeks, 6 weeks, 3 months, 6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: Robert Wetzel, MD, University Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20230720

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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