Clinical trial Phase III to study whether magnesium sulfate improves nerve block in knee surgeries.

Phase 3

Not yet recruiting

• Conditions: Total knee arthroplasty

• Registration Number: 2024-518601-17-00
• Lead Sponsor: Fundacion Progreso Y Salud

Brief Summary

Evaluate the efficacy of perineural magnesium sulfate in prolonging analgesia when administered as an adjuvant to the local anesthetic ropivacaine in total knee arthroplasty.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 131

Inclusion Criteria

Patients scheduled for total knee arthroplasty due to gonarthrosis

ASA I, II, and III patients of both sexes.

Age between 18 and 80 years.

Informed consent signed, accepting participation in the study.

Exclusion Criteria

Allergy or intolerance to local anesthetics, morphine or its derivatives, magnesium sulfate.

Patients with any condition that prevents the use of regional analgesia: anticoagulated, antiplatelet therapy, local or systemic infection.

Patients with difficulty understanding study-related information and collaborating in pain assessment.

Patients with major psychiatric pathology as per DSM-V.

Pregnancy and/or breastfeeding.

ASA IV Patients

Diabetes mellitus with the last glycated hemoglobin control greater than 7%.

Patients with neuromuscular diseases.

Morbid obesity.

Fibromyalgia

Myofascial pain syndrome.

Patients with prior treatment with corticosteroids or calcium antagonists in the last three months.

Patients with cardiovascular disease (congestive heart failure, severe valvular disease, symptomatic coronary artery disease, and/or congenital/anatomical heart abnormalities).

Patients with severe renal, hepatic, or respiratory disease.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time in minutes elapsed from when the patient receives the adductor canal block until the first request for rescue analgesia.		Time in minutes elapsed from when the patient receives the adductor canal block until the first request for rescue analgesia.

Trial Locations

Locations (1)

Hospital Universitario Juan Ramon Jimenez; 🇪🇸 Huelva, Spain

Hospital Universitario Juan Ramon Jimenez

🇪🇸Huelva, Spain

Dolores Diaz Lara

Site contact

+34959016000

mddiazlara@gmail.com