Magnesium as an Adjuvant Agent for Postoperative Pain

Sponsor

University Hospitals Cleveland Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05947760

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: IV Magnesium Sulfate	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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
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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 89 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

University Hospitals Cleveland Medical Center

Investigators

Principal Investigator: Robert Wetzel, MD, University Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert Wetzel, MD, Orthopedic Trauma Surgeon, University Hospitals Cleveland Medical Center

ClinicalTrials.gov Identifier:

NCT05947760

Other Study ID Numbers:

STUDY20230720

First Posted:

Jul 17, 2023

Last Update Posted:

Jul 17, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Robert Wetzel, MD, Orthopedic Trauma Surgeon, University Hospitals Cleveland Medical Center

periacetabular osteotomy

IV magnesium sulfate

Decreased opioid usage

Additional relevant MeSH terms:

Pain, Postoperative

Magnesium Sulfate

Study Results

No Results Posted as of Jul 17, 2023