Comparison of Mean Duration of Analgesia Following the Administration of Bupivacaine With and Without Magnesium Sulphate in Ultrasound Guided Erector Spinae Plane Block in Modified Radical Mastectomy Patients

March 7, 2026 updated by: Fareeha Afzaal, Gulab Devi Hospital
To compare mean duration of postoperative analgesia following the administration of bupivacaine with and without magnesium sulphate in erector spinae plane block in modified radical mastectomy patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is a difference in mean duration of analgesia following the administration of bupivacaine with and without magnesium sulphate in erector spinae plane block in modified radical mastectomy patients.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54600
        • Gulab Devi Hospital Ferozpur Road Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female patients having ASA 1 and Il being aged 2 5 - 60 years and undergoing one sided breast cancer surgery * Patients who sign written informed consent to participate in the study.

Exclusion Criteria:

  • Patients having contraindications for regional blocks (c.g., infection a t the injection site, coagulopathy), allergy to the drugs used i n the study Patients who received radiotherapy, and patients need axillary dissection • Patients with known hypersensitivity to local anesthetic drug (Bupivacaine). Patients with coagulation disorders or receiving anti-coagulant therapy (INR>2.0).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group bupivacaine
20 ml of 0.25% bupivacaine
Drug: Group B (bupivacaine)
receive 20 ml of 0.25% bupivacaine on the operated side for the Erector Spinae Plane (ESP) block.
Other Names:
  • Group bupivacaine
Experimental: Group BMG(bupivacaine plus magnesium sulfate)
20 ml of 0.25% bupivacaine plus 250 mg of magnesium sulfate
Drug: Bupivacaine plus magnesium sulfate
20 ml of 0.25% bupivacaine plus 250 mg of magnesium sulfate on each side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative analgesia
Time Frame: 20 minutes
There is a difference in mean duration of analgesia following the administration of bupivacaine with and without magnesium sulphate in erector spinae plane block in modified radical mastectomy patients.
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulab Devi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2025

Primary Completion (Actual)

November 28, 2025

Study Completion (Actual)

November 28, 2025

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 7, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAMC/IRB/EA/47/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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