Magnesium Sulfate on Postoperative Pain

Study Overview
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Brief Summary
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Breast cancer is the most diagnosed type of cancer in women in Turkey and in the world. According to the World Health Organization data, the rate of newly diagnosed breast cancer was reported as 11.6% in 20181. Acute postoperative pain occurs in 40% of patients undergoing surgery for breast cancer2. In the early postoperative period, opioids are commonly used analgesics in the treatment of pain, but they have various side effects such as gastrointestinal, urinary and respiratory symptoms3. Non-opioid analgesics can be used to reduce opioid use and thus limit its side effects. Magnesium sulfate (MgSO4) is an N-Methyl D-Aspartate (NMDA) receptor antagonist that has been used for postoperative analgesia and reducing both the duration and intensity of pain by preventing central sensitization in response to peripheral painful stimulus4-9. The primary aim of this study is to investigate the postoperative analgesic efficacy of MgSO4 in patients who were scheduled for mastectomy with the diagnosis of breast cancer. The secondary aim of our study is to evaluate the changes in perioperative vital signs that may occur due to MgSO4.

Official Title
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The Effect of Preemptive Magnesium Sulfate on Postoperative Pain in Patients Undergoing Mastectomy

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: normal saline isotonic solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female breast cancer patients scheduled for mastectomy and modified radical mastectomy 18≥ years and Patients with ASA score I-II Exclusion Criteria: The patient who refused the study Drug allergy Unregulated diabetes mellitus and hypertension Cardiac failure with <45% ejection fraction Renal failure (serum creatinine > 2 mg/dL) Liver failure (blood transaminase values 2 fold higher than normal) Glaucoma Psychiatric or neurological disorders Communication difficulties with patient Calcium channel blockers or narcotic drugs uses before surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>The study group (Group I) was given 50 mg/kg MgSO4 in 250 ml of isotonic 30 minutes before induction, | Drug: Magnesium Sulfate<br>* Magnesium sulfate (MgSO4) is an N-Methyl D-Aspartate (NMDA) receptor antagonist that has been used for postoperative analgesia and reducing both the duration and intensity of pain by preventing central sensitization in response to peripheral painful stimulus4-9.<br>|
| Placebo Comparator: Group II<br>the control group (Group II) was given only 250 ml of normal saline isotonic solution 30 minutes before induction, | Drug: normal saline isotonic solution<br>* only 250 ml of normal saline isotonic solution 30 minutes before induction,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain was measured and recorded with the Verbal Numeric Rating Scale | Postoperative pain was measured and recorded with the Verbal Numeric Rating Scale (VNRS) (0 no pain-10 very pain). | 24 hours |