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

NCT06445829 | Not Yet Recruiting

• 1 other identifier: 202400399A3
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

intraarticular injection

Outcome Measures

Primary Outcomes (4)

• VAS score

  day 0, day 1, day 2, day 3, day 7

• muscle power

  day 0, day 1, day 2, day 3

• Straight leg raised test

  day 0, day 1, day 2, day 3

• active range of motion

  day 0, day 1, day 2, day 3

Secondary Outcomes (2)

• Magnesium level in blood

  day 0, day 1

• Calcium level in blood

  day 0, day 1

Study Arms (2)

Cocktail injection with Magnesium Sulfate

EXPERIMENTAL

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

Drug: Magnesium sulfate

Cocktail injection without Magnesium Sulfate

NO INTERVENTION

Cocktail injection with Marcaine, Dexamethasone, and normal saline

Interventions

Magnesium sulfate DRUG

adding 300mg magnesium sulfate into cocktail injection

Cocktail injection with Magnesium Sulfate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• hypersensitivity to magnesium sulfate
• hypermagnesemia
• severe cardiac, hepatic or renal compromised

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (2)

• 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.

  PMID: 37060089 RESULT

• 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.

  PMID: 36856693 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Shih Hui Peng

CONTACT

+886975360757; b9502066@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: June 6, 2024
• Study Start: June 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 6, 2024

Record last verified: 2024-05