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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06445829
Other study ID # 202400399A3
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date April 2026

Study information

Verified date May 2024
Source Chang Gung Memorial Hospital
Contact Shih Hui Peng
Phone +886975360757
Email b9502066@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date April 2026
Est. primary completion date April 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Magnesium sulfate
adding 300mg magnesium sulfate into cocktail injection

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

References & Publications (2)

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- — View Citation

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/s1301 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary VAS score day 0, day 1, day 2, day 3, day 7
Primary muscle power day 0, day 1, day 2, day 3
Primary Straight leg raised test day 0, day 1, day 2, day 3
Primary active range of motion day 0, day 1, day 2, day 3
Secondary Magnesium level in blood day 0, day 1
Secondary Calcium level in blood day 0, day 1
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