Magnesium as an Adjuvant Agent for Postoperative Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: IV Magnesium Sulfate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV Magnesium Sulfate adjuvant group<br>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<br>* Participants will receive IV Magnesium Sulfate intraoperatively.<br>|
| No Intervention: Control group<br>Participants in this group will receive standard-of-care procedures intraoperatively and post-operatively for pain control. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PROMIS scores | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periacetabular osteotomy, IV magnesium sulfate, Decreased opioid usage