Magnesium Sulfate on Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05880732
• Other study ID #: PAU123
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: May 2023
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Female breast cancer patients scheduled for mastectomy and modified radical mastectomy

2. 18= years and

3. Patients with ASA score I-II

Exclusion Criteria:

1. The patient who refused the study

2. Drug allergy

3. Unregulated diabetes mellitus and hypertension

4. Cardiac failure with <45% ejection fraction

5. Renal failure (serum creatinine > 2 mg/dL)

6. Liver failure (blood transaminase values 2 fold higher than normal)

7. Glaucoma

8. Psychiatric or neurological disorders

9. Communication difficulties with patient

10. Calcium channel blockers or narcotic drugs uses before surgery

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Magnesium Sulfate
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.
• normal saline isotonic solution
only 250 ml of normal saline isotonic solution 30 minutes before induction,

Locations

Country	Name	City	State
Turkey	Pamukkale Univercity Medical School	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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