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Magnesium Sulfate on Postoperative Pain

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Magnesium Sulfate
normal saline isotonic solution
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Pamukkale Univercity Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group I

Group II

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
April 5, 2023
Last Updated
May 25, 2023
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05880732
Brief Title
Magnesium Sulfate on Postoperative Pain
Official Title
The Effect of Preemptive Magnesium Sulfate on Postoperative Pain in Patients Undergoing Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
The study group (Group I) was given 50 mg/kg MgSO4 in 250 ml of isotonic 30 minutes before induction,
Arm Title
Group II
Arm Type
Placebo Comparator
Arm Description
the control group (Group II) was given only 250 ml of normal saline isotonic solution 30 minutes before induction,
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
normal saline isotonic solution
Intervention Description
only 250 ml of normal saline isotonic solution 30 minutes before induction,
Primary Outcome Measure Information:
Title
Postoperative pain was measured and recorded with the Verbal Numeric Rating Scale
Description
Postoperative pain was measured and recorded with the Verbal Numeric Rating Scale (VNRS) (0 no pain-10 very pain).
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Pamukkale Univercity Medical School
City
Denizli
ZIP/Postal Code
20070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Magnesium Sulfate on Postoperative Pain

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