Arthropathy of Knee Clinical Trial
Official title:
Neuroendocrine Changes Associated With Magnesium Sulfate Administration in Surgical Patients
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 15, 2021 |
Est. primary completion date | December 15, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Seoul National University Bundang Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The profiles of cortisol in the saliva | 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 | 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 | |
Primary | The profiles of dehydroepiandrosterone (DHEA) in the saliva | 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 | 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 | |
Secondary | Postoperative pain | Numerical rating scale pain score | Postoperative 24 hour | |
Secondary | Postoperative pain | Numerical rating scale pain score | Postoperative 48 hour | |
Secondary | Patient controlled analgesia (PCA) | Amounts of PCA consumption | Postoperative 24 hour | |
Secondary | Patient controlled analgesia (PCA) | Amounts of PCA consumption | Postoperative 48 hour | |
Secondary | Nausea | Incidence of nausea | Postoperative 24 hour | |
Secondary | Nausea | Incidence of nausea | Postoperative 48 hour | |
Secondary | Vomiting | Incidence of vomiting | Postoperative 24 hour | |
Secondary | Vomiting | Incidence of vomiting | Postoperative 48 hour | |
Secondary | Anti-emetics | Amounts of anti-emetics consumption | Postoperative 24 hour | |
Secondary | Anti-emetics | Amounts of anti-emetics consumption | Postoperative 48 hour |
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