Magnesium as an Adjuvant Agent for Postoperative Pain

Phase 4

Recruiting

• Conditions: Pain, Postoperative
• Interventions: Drug: IV Magnesium Sulfate

• Registration Number: NCT05947760
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-07-05
• Study First Posted: 2023-07-17
• Status Verified: 2025-03
• Study Start: 2025-03-10
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Magnesium Sulfate adjuvant group	IV Magnesium Sulfate	Participants in this group will receive standard-of-care procedures intraoperatively and postoperatively along with IV magnesium sulfate for pain control.

Primary Outcome Measures

Name	Time	Method
Change in number of narcotic medications consumed as measured by the medical record review	Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Change in pain as measured by the Visual Analog Scale (VAS)	Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year	The VAS is a scale from 0-10 with 0 being no pain and 10 being the worst pain ever

Secondary Outcome Measures

Name	Time	Method
Change in PROMIS scores	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.
Change in modified Harris Hip Scores (mHHS)	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

Trial Locations

Locations (1)

University Hospitals; 🇺🇸 Cleveland, Ohio, United States