Arthropathy of Knee, Cortisol, Dehydroepiandrosterone, Magnesium Sulfate
Conditions
Brief summary
Total knee arthroplasty is a procedure that relieves pain in patients with severe symptomatic osteoarthritis, but it can be associated with postoperative pain, which hinders recovery. In the previous study, we reported evidence of increased pain in patients undergoing staged total knee arthroplasty, in whom the second operated knee had greater sensitivity (tertiary hyperalgesia) as a result of the surgical injury to the first operated knee. Magnesium sulfate is an effective analgesic adjuvant for postoperative pain. Its analgesic property seems to be associated with the regulation of calcium influx into the cells, or antagonism of N-methyl-D-aspartate receptors in the central nervous system. Additionally, magnesium is known to have an anti-inflammatory effect. Inflammatory state may accompany with pain via peripheral or central sensitization. Recently, we reported that magnesium sulfate effectively attenuates not only postoperative pain but also increased pain intensity without serious adverse effects in the bilateral staged total knee arthroplasty. However, the exact mechanism regarding these effects of magnesium sulfate remains unclear. In the present study, we will investigate the analgesic mechanism of magnesium sulfate via analysis of endocrine neurosteroid levels in patients undergoing bilateral staged total knee arthroplasty.
Interventions
DRUGMagnesium sulfate
Magnesium group receives magnesium sulfate (50 mg/kg) in 100 mL of isotonic saline over 15 minutes after spinal anesthesia, followed by a continuous magnesium sulfate infusion (15 mg/kg/hour) until the end of surgery.
DRUGIsotonic Saline
Isotonic saline group receives the same volume of isotonic saline, administered according to the same methods as in the magnesium group.
Sponsors
Seoul National University Bundang Hospital
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who undergo staged bilateral total knee arthroplasty * Spinal anesthesia * American Society of Anesthesiologists physical status 1 and 2
Exclusion criteria
* Patients who undergo unilateral total knee arthroplasty * General anesthesia * Musculoskeletal disease * Hypermagnesemia * Atrioventricular block * Previous history of administration of calcium channel blockers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The profiles of cortisol in the saliva | From the evening (21:00) before the operation day to the morning (60 minutes after wake-up) of the operation day, for each stage of the operation | The cortisol concentrations in the saliva, at the evening before the operation (21:00\ 22:00), just after wake-up in the morning of the operation day, and 30 and 60 minutes after wake-up |
| The profiles of dehydroepiandrosterone (DHEA) in the saliva | From the evening (21:00) before the operation day to the morning (60 minutes after wake-up) of the operation day, for each stage of the operation | The DHEA concentrations in the saliva, at the evening before the operation (21:00\ 22:00), just after wake-up in the morning of the operation day, and 30 and 60 minutes after wake-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea | Postoperative 24 hour | Incidence of nausea |
| Postoperative pain | Postoperative 24 hour | Numerical rating scale pain score |
| Anti-emetics | Postoperative 24 hour | Amounts of anti-emetics consumption |
| Vomiting | Postoperative 24 hour | Incidence of vomiting |
| Patient controlled analgesia (PCA) | Postoperative 24 hour | Amounts of PCA consumption |
Countries
South Korea
Contacts
Primary ContactHyun-Jung Shin, MD., PhD.
Outcome results
None listed