Magnesium Sulfate on Postoperative Pain

NCT05880732 | Completed

• 1 other identifier: PAU123
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group I

EXPERIMENTAL

The study group (Group I) was given 50 mg/kg MgSO4 in 250 ml of isotonic 30 minutes before induction,

Drug: Magnesium Sulfate

Group II

PLACEBO COMPARATOR

the control group (Group II) was given only 250 ml of normal saline isotonic solution 30 minutes before induction,

Drug: normal saline isotonic solution

Interventions

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.

Group I

normal saline isotonic solution DRUG

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

Group II

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female breast cancer patients scheduled for mastectomy and modified radical mastectomy
• ≥ years and
• Patients with ASA score I-II

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale Univercity Medical School

Denizli, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor doctor

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 30, 2023
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)