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Completed

NCT Number: NCT05880732

Magnesium Sulfate on Postoperative Pain

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale Univercity Medical School

Denizli, 20070, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate

Drug

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

Drug

only 250 ml of normal saline isotonic solution 30 minutes before induction,

Primary outcomes

  1. Postoperative pain was measured and recorded with the Verbal Numeric Rating Scale

    Time frame: 24 hours

    Postoperative pain was measured and recorded with the Verbal Numeric Rating Scale (VNRS) (0 no pain-10 very pain).

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 30, 2023
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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