Magnesium Sulfate Combined With Intraarticular Cocktail Injection for Analgesia After Simultaneous Bilateral Total Knee Arthroplasty

NCT ID: NCT06445829

Last Updated: 2024-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cocktail injection with Magnesium Sulfate

Cocktail injection with Marcaine, Dexamethasone, normal saline and Magnesium Sulfate

Group Type EXPERIMENTAL

Magnesium sulfate

Intervention Type DRUG

adding 300mg magnesium sulfate into cocktail injection

Cocktail injection without Magnesium Sulfate

Cocktail injection with Marcaine, Dexamethasone, and normal saline

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Magnesium sulfate

adding 300mg magnesium sulfate into cocktail injection

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* bilateral knee advanced osteoarthritis or osteonecrosis who tend to receive simultaneous bilateral total knee arthroplasty

Exclusion Criteria

* hypersensitivity to magnesium sulfate
* hypermagnesemia
* severe cardiac, hepatic or renal compromised
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shih Hui Peng

Role: CONTACT

+886975360757

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 37060089 (View on PubMed)

Wang 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.

Reference Type RESULT
PMID: 36856693 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202400399A3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.