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The Effects of Intravenous Combined with Topical Application of Magnesium Sulfate on Postoperative Pain, Stress Response, and Functional Recovery after Total Knee Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Trial

The Effects of Intravenous Combined with Topical Application of Magnesium Sulfate on Postoperative Pain, Stress Response, and Functional Recovery after Total Knee Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107495
Enrollment
Unknown
Registered
2025-08-12
Start date
2025-08-15
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the knee

Interventions

Intravenous magnesium sulfate group:During the anesthesia induction period, 100ml of isotonic saline solution containing 2g of magnesium sulfate was intravenously infused within 15 minutes, and then m
Local magnesium sulfate group:Add 250mg of magnesium sulfate to the routine local infiltration cocktail during the operation.
The group of combined intravenous and local application of magnesium sulfate:Magnesium sulfate should be applied both intravenously and locally in accordance with the above methods.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients who need to undergo the initial unilateral total knee arthroplasty due to severe osteoarthritis of the knee joint; (2) Age ranging from 18 to 80 years old; (3) The preoperative classification (anesthesia risk assessment) of the American Society of Anesthesiologists (ASA) was grade I to III.

Exclusion criteria

Exclusion criteria: (1) Patients with failure of vital organs such as the heart and lungs; (2) Abnormal liver and kidney functions (ALT, AST> 1.5 times the normal value, blood BUN>-8.3 mmoll, blood Scr>115 umol/L); (3) Diabetic patients with poorly controlled blood sugar levels, who are judged by researchers to be at risk of infection; (4) Combined with consciousness disorders or mental illnesses; (5) Have a history of open knee surgery; (6) There is neuromuscular dysfunction affecting the function of the lower extremities; (7) Patients with severe coagulation dysfunction; (8) Combined with severe internal or surgical diseases or weak constitution, unable to tolerate surgery; (9) Severely unstable and incurable with ligament-preserving TKA; (10) There are active infection foci in the body (with infection lesions throughout the body or locally); (11) There is severe osteoporosis, metabolic bone disease, radiation bone disease or tumor around the knee joint; (12) Women in family planning, lactation and pregnancy throughout the entire clinical research period; (13) Those who have participated in other clinical trials within the past three months; (14) Those who the researcher deems unsuitable to participate in this clinical trial for other reasons; (15) Knee flexion deformity >= 30° or varus and valgus deformity >= 30°; (16) Those who are allergic to the drugs used in this study; (17) Opioid addicts; (18) Those with language disorders and unable to complete the Visual analogue scale (VAS) for pain.

Design outcomes

Primary

MeasureTime frame
Dosage of morphine hydrochloride injection for postoperative rescue;Postoperative VAS pain score;

Secondary

MeasureTime frame
The dosage of opioids during the surgery;The dosage of anesthetic inhaled during the operation;Incidence of intraoperative hypertension;Postoperative serum cortisol and ACTH levels;Postoperative knee joint range of motion;Postoperative walking ability test;Postoperative duration of hospital stay;Incidence of postoperative complications;

Countries

China

Contacts

Public ContactPengde Kang

West China Hospital, Sichuan University

kangpengd@163.com+86 189 8060 1953

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026