Osteoarthritis, KneeNCT06445829
Magnesium Sulfate Combined With Intraarticular Cocktail Injection for Analgesia After Simultaneous Bilateral Total Knee Arthroplasty
A study testing Magnesium sulfate in people with Osteoarthritis, Knee, run by Chang Gung Memorial Hospital.
Trial summary
Total knee arthroplasty is a safe procedure with excellent outcome. In recent years, simultaneous bilateral total knee arthroplasty has become more popular. In views of enhanced recovery after surgery, intraarticular cocktail injection for pain control has been developed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Apr 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- bilateral knee advanced osteoarthritis or osteonecrosis who tend to receive simultaneous bilateral total knee arthroplasty
Who cannot join
- hypersensitivity to magnesium sulfate
- hypermagnesemia
- severe cardiac, hepatic or renal compromised
Trial locations and contacts
No sites are listed yet.
About this study
Total knee arthroplasty is a safe procedure with excellent outcome. In recent years, simultaneous bilateral total knee arthroplasty has become more popular. In views of enhanced recovery after surgery, intraarticular cocktail injection for pain control has been developed. However, the safety accumulation dose for simultaneous bilateral knee injection is still an issue. Recently, adding magnesium sulfate to intraarticular cocktail injection in unilateral total knee arthroplasty has been proved effective for prolong pain control. We tempt to conduct a double blinded study to evaluate that whether adding magnesium sulfate intraarticular cocktail injection to one of the knees in simultaneous bilateral total knee arthroplasty patient could effectively decrease pain score with less analgesia dose or not.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Magnesium sulfate
- Keywords
- intraarticular injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
adding 300mg magnesium sulfate into cocktail injection
| Study group | Role | What they receive |
|---|---|---|
| Cocktail injection with Magnesium Sulfate | Experimental | Cocktail injection with Marcaine, Dexamethasone, normal saline and Magnesium Sulfate Receives: Drug: Magnesium sulfate |
| Cocktail injection without Magnesium Sulfate | No intervention | Cocktail injection with Marcaine, Dexamethasone, and normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
Measured: day 0, day 1, day 2, day 3, day 7
muscle power
Measured: day 0, day 1, day 2, day 3
Straight leg raised test
Measured: day 0, day 1, day 2, day 3
active range of motion
Measured: day 0, day 1, day 2, day 3
Secondary outcomes (2)
Magnesium level in blood
Measured: day 0, day 1
Calcium level in blood
Measured: day 0, day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445829
- Sponsor's protocol ID
- 202400399A3
- Status last verified
- May 2024
- First submitted
- 2 Jun 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhao C, Wang L, Chen L, Wang Q, Kang P. Effects of magnesium sulfate on periarticular infiltration analgesia in total knee arthroplasty: a prospective, double-blind, randomized controlled trial. J Orthop Surg Res. 2023 Apr 14;18(1):301. doi: 10.1186/s13018-023-03790-w.
PubMed 37060089Wang Q, Zhao C, Hu J, Ma T, Yang J, Kang P. Efficacy of a Modified Cocktail for Periarticular Local Infiltration Analgesia in Total Knee Arthroplasty: A Prospective, Double-Blinded, Randomized Controlled Trial. J Bone Joint Surg Am. 2023 Mar 1;105(5):354-362. doi: 10.2106/JBJS.22.00614. Epub 2023 Mar 1.
PubMed 36856693
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Sulfate Combined With Intraarticular Cocktail Injection for Analgesia After Simultaneous Bilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06445829
- Acronym / sponsor ID
- 202400399A3
- Conditions
- Osteoarthritis, Knee
- Keywords
- intraarticular injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 6 Jun 2024 (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.
Total knee arthroplasty is a safe procedure with excellent outcome. In recent years, simultaneous bilateral total knee arthroplasty has become more popular. In views of enhanced recovery after surgery, intraarticular cocktail injection for pain control has been developed. However, the safety accumulation dose for simultaneous bilateral knee injection is still an issue. Recently, adding magnesium sulfate to intraarticular cocktail injection in unilateral total knee arthroplasty has been proved effective for prolong pain control. We tempt to conduct a double blinded study to evaluate that whether adding magnesium sulfate intraarticular cocktail injection to one of the knees in simultaneous bilateral total knee arthroplasty patient could effectively decrease pain score with less analgesia dose or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cocktail injection with Magnesium Sulfate | Experimental | Drug: Magnesium sulfateCocktail injection with Marcaine, Dexamethasone, normal saline and Magnesium Sulfate |
| Cocktail injection without Magnesium Sulfate | No intervention | –Cocktail injection with Marcaine, Dexamethasone, and normal saline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- bilateral knee advanced osteoarthritis or osteonecrosis who tend to receive simultaneous bilateral total knee arthroplasty
Key exclusion criteria (3 listed)
- hypersensitivity to magnesium sulfate
- hypermagnesemia
- severe cardiac, hepatic or renal compromised
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 |
|---|---|---|
| Magnesium sulfateadding 300mg magnesium sulfate into cocktail injection | Drug | Cocktail injection with Magnesium Sulfate |
Primary outcome
VAS score
Time frame: day 0, day 1, day 2, day 3, day 7
muscle power
Time frame: day 0, day 1, day 2, day 3
Straight leg raised test
Time frame: day 0, day 1, day 2, day 3
active range of motion
Time frame: day 0, day 1, day 2, day 3
2 secondary outcomes
Magnesium level in blood
Time frame: day 0, day 1
Calcium level in blood
Time frame: day 0, day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Results publication: PubMed 37060089Zhao C, Wang L, Chen L, Wang Q, Kang P. Effects of magnesium sulfate on periarticular infiltration analgesia in total knee arthroplasty: a prospective, double-blind, randomized controlled trial. J Orthop Surg Res. 2023 Apr 14;18(1):301. doi: 10.1186/s13018-023-03790-w.
- Results publication: PubMed 36856693Wang Q, Zhao C, Hu J, Ma T, Yang J, Kang P. Efficacy of a Modified Cocktail for Periarticular Local Infiltration Analgesia in Total Knee Arthroplasty: A Prospective, Double-Blinded, Randomized Controlled Trial. J Bone Joint Surg Am. 2023 Mar 1;105(5):354-362. doi: 10.2106/JBJS.22.00614. Epub 2023 Mar 1.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulfate in people with Osteoarthritis, Knee, run by Chang Gung Memorial Hospital.
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 3 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: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shih Hui Peng (+886975360757, b9502066@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: day 0, day 1, day 2, day 3, day 7). The study lists 4 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 NCT06445829, which also lists 2 linked publications.
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 6 Jun 2024.