Clinical trial • Phase III • Other

MAGNESIUM SULFATE for Knee osteoarthritis (gonarthrosis) | Total knee arthroplasty

Phase III trial of MAGNESIUM SULFATE for Knee osteoarthritis (gonarthrosis) | Total knee arthroplasty.

Overview

Trial Therapeutic Area
Other
Trial Disease
Knee osteoarthritis (gonarthrosis) | Total knee arthroplasty
Trial Stage
Phase III
Drug Modality
Small molecule | Other

Key dates

Initial CTIS Submission Date
02-10-2024
First CTIS Authorization Date
14-10-2024

Trial design

Randomised, saline placebo (solution for injection) used as comparator; auxiliary local anesthetic ropivacaine hydrochloride administered as part of the procedure. documented dosing information: magnesium sulfate (test) max total dose 6 g; ropivacaine hydrochloride (auxiliary) max total dose 300 mg; saline (placebo) dosing fields present (max daily 100 g, max total 1000 g) but schedule not specified.-controlled Phase III trial across 1 site in Spain.

Randomised
Yes
Comparator
Saline placebo (solution for injection) used as comparator; auxiliary local anesthetic Ropivacaine hydrochloride administered as part of the procedure. Documented dosing information: Magnesium sulfate (test) max total dose 6 g; Ropivacaine hydrochloride (auxiliary) max total dose 300 mg; Saline (placebo) dosing fields present (max daily 100 g, max total 1000 g) but schedule not specified.
Target Sample Size
131

Eligibility

Recruits 131 Vulnerable population not selected. Informed consent is required ("Informed consent signed, accepting participation in the study."). Patients with difficulty understanding study-related information and collaborating in pain assessment are explicitly excluded. Age range is 18-80 years, so minors are excluded; no assent process described..

Pregnancy Exclusion
Pregnancy and/or breastfeeding.
Vulnerable Population
Vulnerable population not selected. Informed consent is required ("Informed consent signed, accepting participation in the study."). Patients with difficulty understanding study-related information and collaborating in pain assessment are explicitly excluded. Age range is 18-80 years, so minors are excluded; no assent process described.

Inclusion criteria

  • {"criterion_text":"-Patients scheduled for total knee arthroplasty due to gonarthrosis"}
  • {"criterion_text":"-ASA I, II, and III patients of both sexes."}
  • {"criterion_text":"-Age between 18 and 80 years."}
  • {"criterion_text":"-Informed consent signed, accepting participation in the study."}

Exclusion criteria

  • {"criterion_text":"-Allergy or intolerance to local anesthetics, morphine or its derivatives, magnesium sulfate."}
  • {"criterion_text":"-Patients with any condition that prevents the use of regional analgesia: anticoagulated, antiplatelet therapy, local or systemic infection."}
  • {"criterion_text":"-Patients with difficulty understanding study-related information and collaborating in pain assessment."}
  • {"criterion_text":"-Patients with major psychiatric pathology as per DSM-V."}
  • {"criterion_text":"-Pregnancy and/or breastfeeding."}
  • {"criterion_text":"-ASA IV Patients"}
  • {"criterion_text":"-Diabetes mellitus with the last glycated hemoglobin control greater than 7%."}
  • {"criterion_text":"-Patients with neuromuscular diseases."}
  • {"criterion_text":"-Morbid obesity."}
  • {"criterion_text":"-Fibromyalgia"}
  • {"criterion_text":"-Myofascial pain syndrome."}
  • {"criterion_text":"-Patients with prior treatment with corticosteroids or calcium antagonists in the last three months."}
  • {"criterion_text":"-Patients with cardiovascular disease (congestive heart failure, severe valvular disease, symptomatic coronary artery disease, and/or congenital/anatomical heart abnormalities)."}
  • {"criterion_text":"-Patients with severe renal, hepatic, or respiratory disease."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Time in minutes elapsed from when the patient receives the adductor canal block until the first request for rescue analgesia.","definition_or_measurement_approach":"Measured as time in minutes from administration of the adductor canal block to the patient's first request for rescue analgesia."}

Recruitment

Planned Sample Size
131
Recruitment Window Months
41
Consent Approach
Informed consent must be signed by participants ("Informed consent signed, accepting participation in the study."). Age eligibility is 18-80 years (adults only). A subject information and informed consent form document is listed but languages and age-specific documents or assent procedures are not specified.

Geography

Total Number Of Sites
1
Total Number Of Participants
131

Spain

Earliest CTIS Part Ii Submission Date
09-10-2024
Latest Decision Or Authorization Date
14-10-2024
Processing Time Days
5
Number Of Sites
1
Number Of Participants
131

Sites

Site Name
Hospital Universitario Juan Ramon Jimenez
Department Name
anesthetist
Contact Person Name
Dolores Diaz Lara
Contact Person Email
mddiazlara@gmail.com

Sponsor

Primary sponsor

Full Name
Fundacion Progreso Y Salud
Organisation Type
Patient organisation/association
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
MAGNESIUM SULFATE
Active Substance
MAGNESIUM SULFATE
Modality
Small molecule
Routes Of Administration
Injection
Route
Injection
Authorisation Status
No marketing authorisation
Dose Levels
Max total dose 6 g
Maximum Dose
6 g
Investigational Product Name
ROPIVACAINE HYDROCHLORIDE
Active Substance
ROPIVACAINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
Injection
Route
Injection
Authorisation Status
No marketing authorisation
Dose Levels
Max total dose 300 mg
Maximum Dose
300 mg
Investigational Product Name
SALINE
Active Substance
SALINE
Modality
Other
Routes Of Administration
Injection
Route
Injection
Authorisation Status
No marketing authorisation
Dose Levels
Max daily dose 100 g; max total dose 1000 g
Maximum Dose
1000 g
Combination Treatment
Yes

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