Magnesium as an Adjuvant Agent for Postoperative Pain

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05947760
• Other study ID #: STUDY20230720
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Elika Fanaeian, MS
• Phone: 7608846031
• Email: elika.fanaeian[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• IV Magnesium Sulfate
Participants will receive IV Magnesium Sulfate intraoperatively.

Locations

Country	Name	City	State
United States	University Hospitals	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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