Magnesium and Postoperative Pain

Phase 4

Terminated

• Conditions: Arthritis Knee; Magnesium Sulfate; Dexmedetomidine
• Interventions: Drug: Normal saline; Drug: Magnesium Sulfate

• Registration Number: NCT03253224
• Lead Sponsor: Seoul National University Hospital

Brief Summary

With ongoing advancements in healthcare leading to prolonged life expectancy, orthopedic surgeries are increasingly performed in elderly patients. Total knee arthroplasty, in particular, has been increasing with the growing demand for improved mobility and quality of life. Total knee arthroplasty is performed on patients with advanced and painful osteoarthritis of the knees, but it can result in moderate to severe postoperative pain during the recovery period.

To relieve anxiety or stress during surgery under regional anesthesia, sedation can be provided. Dexmedetomidine is a sedative-analgesic agent acting as α2-adrenergic receptor agonist, and its analgesic effect has been well established in various procedures or surgeries.

Magnesium has been reported to produce important analgesic effects including the suppression of neuropathic pain, potentiation of morphine analgesia, and attenuation of morphine tolerance. Although the exact mechanism is not yet fully understood, the analgesic properties of magnesium are believed to stem from regulation of calcium influx into the cell and antagonism of N-methyl-D-aspartate (NMDA) receptors in the central nervous system. In this study, investigators will evaluate the reducing effect of magnesium on the post-total knee arthroplasty pain in patients sedated with dexmedetomidine under spinal anesthesia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-17
• Study Start: 2017-09-10
• Status Verified: 2017-12
• Primary Completion: 2018-03-29
• Study Completion: 2018-03-29
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Patients who undergo total knee arthroplasty under spinal anesthesia
• Patients who want to sedation during the surgery
• American Society of Anesthesiologists physical status classification 1 and 2

Exclusion Criteria

• General anesthesia
• Patients who do not want to sedation during the surgery
• Patients who do not receive patient controlled analgesia postoperatively
• Muscular disease
• Hypermagnesemia
• Atrioventricular block

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Normal saline	Patient who received normal saline during the operation
Magnesium	Magnesium Sulfate	Patient who received magnesium sulfate during the operation

Primary Outcome Measures

Name	Time	Method
Patient controlled analgesia (PCA)	Postoperative 24 hour	Amounts of PCA consumption

Secondary Outcome Measures

Name	Time	Method
Numerical rating scale	Postoperative 24 hour	Postoperative pain score
Nausea	Postoperative 24 hour	Incidence of nausea
Vomiting	Postoperative 24 hour	Incidence of vomiting
Rescue analgesics	Postoperative 24 hour	Amounts of the analgesics administered to mange the postoperative pain
Antiemetics	Postoperative 24 hour	Amounts of antiemetics consumption

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of