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Magnesium as an Adjuvant Agent for Postoperative Pain

Primary Purpose

Pain, Postoperative

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV Magnesium Sulfate
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring periacetabular osteotomy, IV magnesium sulfate, Decreased opioid usage

Eligibility Criteria

14 Years - 89 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IV Magnesium Sulfate adjuvant group

Control group

Arm Description

Participants in this group will receive standard-of-care procedures intraoperatively and postoperatively along with IV magnesium sulfate for pain control.

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

Outcomes

Primary Outcome Measures

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
Change in number of narcotic medications consumed as measured by the medical record review

Secondary Outcome Measures

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.
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

Full Information

First Posted
July 5, 2023
Last Updated
October 9, 2023
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05947760
Brief Title
Magnesium as an Adjuvant Agent for Postoperative Pain
Official Title
Magnesium as an Adjuvant Agent for Postoperative Pain Control Following Periacetabular Osteotomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
periacetabular osteotomy, IV magnesium sulfate, Decreased opioid usage

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IV Magnesium Sulfate adjuvant group
Arm Type
Experimental
Arm Description
Participants in this group will receive standard-of-care procedures intraoperatively and postoperatively along with IV magnesium sulfate for pain control.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in this group will receive standard-of-care procedures intraoperatively and post-operatively for pain control.
Intervention Type
Drug
Intervention Name(s)
IV Magnesium Sulfate
Intervention Description
Participants will receive IV Magnesium Sulfate intraoperatively.
Primary Outcome Measure Information:
Title
Change in pain as measured by the Visual Analog Scale (VAS)
Description
The VAS is a scale from 0-10 with 0 being no pain and 10 being the worst pain ever
Time Frame
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Title
Change in number of narcotic medications consumed as measured by the medical record review
Time Frame
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Secondary Outcome Measure Information:
Title
Change in PROMIS scores
Description
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.
Time Frame
2 weeks, 6 weeks, 3 months, 6 months, 1 year
Title
Change in modified Harris Hip Scores (mHHS)
Description
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
Time Frame
2 weeks, 6 weeks, 3 months, 6 months, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elika Fanaeian, MS
Phone
7608846031
Email
elika.fanaeian@uhhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Wetzel, MD
Organizational Affiliation
University Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elika Fanaeian, MS
Phone
760-884-6031
Email
elika.fanaeian@uhhospitals.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Magnesium as an Adjuvant Agent for Postoperative Pain

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