NCT05947760

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
4mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Mar 2025Aug 2026

First Submitted

Initial submission to the registry

July 5, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
1.6 years until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

July 5, 2023

Last Update Submit

April 17, 2026

Conditions

Keywords

periacetabular osteotomyIV magnesium sulfateDecreased opioid usage

Outcome Measures

Primary Outcomes (2)

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

    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

    Over the first 7 days post operatively, gathered every 6 hours.

Secondary Outcomes (2)

  • Change in PROMIS scores

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

  • Change in modified Harris Hip Scores (mHHS)

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

Study Arms (2)

IV Magnesium Sulfate adjuvant group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Participants will receive IV Magnesium Sulfate intraoperatively.

IV Magnesium Sulfate adjuvant group

Eligibility Criteria

Age14 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing periacetabular osteotomy with or without adjuvant hip arthroscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • Sinkler MA, Nighswander AJ, Smith KL, Fortier LM, Kodsy MM, Fanaeian E, Salata MJ, Wetzel RJ. MAGNA-PAO: magnesium as an adjuvant for postoperative analgesia in periacetabular osteotomy; a clinical trial protocol. Pain Manag. 2026 Mar 16:1-7. doi: 10.1080/17581869.2026.2645536. Online ahead of print.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Robert Wetzel, MD

    University Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Trauma Surgeon

Study Record Dates

First Submitted

July 5, 2023

First Posted

July 17, 2023

Study Start

March 10, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations