Pain, PostoperativePhase 4NCT05947760
Magnesium as an Adjuvant Agent for Postoperative Pain
A Phase 4 study testing IV Magnesium Sulfate in people with Pain, Postoperative, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 89 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- IV Magnesium Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to 15 Sep 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing periacetabular osteotomy with or without adjuvant hip arthroscopy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnesium as an Adjuvant Agent for Postoperative Pain Control Following Periacetabular Osteotomy
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.
- Conditions
- Pain, Postoperative
- Being tested
- IV Magnesium Sulfate
- Keywords
- periacetabular osteotomy, IV magnesium sulfate, Decreased opioid usage
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Magnesium SulfateDrug
Participants will receive IV Magnesium Sulfate intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| IV Magnesium Sulfate adjuvant group | Experimental | Participants in this group will receive standard-of-care procedures intraoperatively and postoperatively along with IV magnesium sulfate for pain control. Receives: Drug: IV Magnesium Sulfate |
| Control group | No intervention | Participants in this group will receive standard-of-care procedures intraoperatively and post-operatively for pain control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Over the first 7 days post operatively, measured every 6 hours
Change in number of narcotic medications consumed as measured by the medical record review
Measured: Over the first 7 days post operatively, gathered every 6 hours.
Secondary outcomes (2)
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.
Measured: 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
Measured: 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start10 Mar 2025
- Primary completion15 Sep 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Wetzel, MD, University Hospitals Cleveland Medical Center
- Investigators
- Robert Wetzel, MD, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947760
- Sponsor's protocol ID
- STUDY20230720
- Status last verified
- Oct 2026
- First submitted
- 5 Jul 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sinkler MA, Nighswander AJ, Smith KL, Fortier LM, Kodsy MM, Fanaeian E, Salata MJ, Wetzel RJ. MAGNA-PAO: magnesium as an adjuvant for postoperative analgesia in periacetabular osteotomy; a clinical trial protocol. Pain Manag. 2026 Jun;16(6):567-573. doi: 10.1080/17581869.2026.2645536. Epub 2026 Mar 16.
PubMed 41837581
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium as an Adjuvant Agent for Postoperative Pain Control Following Periacetabular Osteotomy
- ClinicalTrials.gov ID
- NCT05947760
- Acronym / sponsor ID
- STUDY20230720
- Conditions
- Pain, Postoperative
- Keywords
- periacetabular osteotomy, IV magnesium sulfate, Decreased opioid usage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Magnesium Sulfate adjuvant group | Experimental | Drug: IV Magnesium SulfateParticipants in this group will receive standard-of-care procedures intraoperatively and postoperatively along with IV magnesium sulfate for pain control. |
| Control group | No intervention | –Participants in this group will receive standard-of-care procedures intraoperatively and post-operatively for pain control. |
Who may qualify
- Ages
- 14 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing periacetabular osteotomy with or without adjuvant hip arthroscopy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV Magnesium SulfateParticipants will receive IV Magnesium Sulfate intraoperatively. | Drug | IV Magnesium Sulfate adjuvant group |
Primary outcome
Change in pain as measured by the Visual Analog Scale (VAS)
Time frame: Over the first 7 days post operatively, measured every 6 hours
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
Time frame: Over the first 7 days post operatively, gathered every 6 hours.
2 secondary outcomes
Change in PROMIS scores
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Change in modified Harris Hip Scores (mHHS)
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Derived from this study: PubMed 41837581Sinkler MA, Nighswander AJ, Smith KL, Fortier LM, Kodsy MM, Fanaeian E, Salata MJ, Wetzel RJ. MAGNA-PAO: magnesium as an adjuvant for postoperative analgesia in periacetabular osteotomy; a clinical trial protocol. Pain Manag. 2026 Jun;16(6):567-573. doi: 10.1080/17581869.2026.2645536. Epub 2026 Mar 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Wetzel, MD principal investigator
University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IV Magnesium Sulfate in people with Pain, Postoperative, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain as measured by the Visual Analog Scale (VAS) (time frame: Over the first 7 days post operatively, measured every 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05947760, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.