Adding Magnesium Sulfate to Local Anesthetic in Combined Pectoral Nerve and Stellate Ganglion Block for Postoperative Pain Control After Modified Radical Mastectomy

May 20, 2026 updated by: Mahmoud Ahmed Ali Ali, Cairo University

Effect of Adding Magnesium Sulfate to Local Anesthetic in Combined Pectoral Nerve and Stellate Ganglion Block for Postoperative Pain Control After Modified Radical Mastectomy

We aim to study the effect of adding magnesium sulfate as an adjuvant to the local anesthetic used in the combined Pectoralis Nerve Block II (PECS II) and stellate ganglion block for postoperative pain control in patients undergoing modified radical mastectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Post-operative pain from breast surgery can be controlled by regular pain medications such as paracetamol, non-steroidal anti-inflammatory (NSAIDs), and narcotics. Nerve blocks are commonly used as multimodal approaches for acute post-operative pain relief.

Pectoral and stellate ganglion blocks are regional anesthesia techniques that target the thoracic nerves and sympathetic nerve ganglia to provide analgesia for the upper extremity and chest regions. When combined, these blocks have shown promising results in alleviating perioperative pain for patients undergoing modified radical mastectomy.

Magnesium sulfate, a well-known adjuvant, has been studied extensively for its analgesic properties and anti-inflammatory effects.

Study Type

Interventional

Enrollment (Actual)

70

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

  • Egypt
      • Cairo, Egypt, 12613
        • Cairo University

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years.
  • Female gender.
  • American Society of Anesthesiologists (ASA) physical status II or III.
  • Patients scheduled for elective modified radical mastectomy for breast cancer.
  • Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.

Exclusion Criteria:

  • Bleeding tendency due to coagulopathy,
  • Patients with opioid dependence or alcohol or drug abuse,
  • Significant liver and renal sufficiency
  • Patients with psychiatric illnesses that prevent them from proper perception and assessment of pain.
  • Local infection at the site of the block.
  • Known hypersensitivity or allergy to magnesium sulfate or local anesthetics.
  • Patients with chronic pain syndromes or pre-existing neuropathic pain conditions.
  • Pregnant or lactating individuals.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Patients will receive the combined pectoralis nerve block II (PECS II)(20 mL) and stellate ganglion block (5 mL) using 0.5% bupivacaine (local anesthetic) without magnesium sulfate.
Drug: Bupivacaine
Patients received the combined pectoralis nerve block II (PECS II) (20 mL) and stellate ganglion block (5 mL) using 0.5% bupivacaine (local anesthetic) without magnesium sulfate.
Experimental: Group B
Patients will receive the combined (20 mL) pectoralis nerve block II (PECS II) and stellate ganglion block (5 mL) using 0.5% bupivacaine (local anesthetic) mixed with 2.5 mL magnesium sulfate (10%), i.e., 250 mg.
Drug: Bupivacaine + Magnesium sulfate
Patients received the combined (20 mL) pectoralis nerve block II (PECS II) and stellate ganglion block (5 mL) using 0.5% bupivacaine (local anesthetic) mixed with 2.5 mL magnesium sulfate (10%), i.e., 250 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total morphine consumption
Time Frame: 24 hours postoperatively
With numeric rating scale (NRS) rest score ≥ 3 or NRS evoked score ≥ 4, morphine will be administered intravenously by a dose of 0.05 mg/kg at 30-minute intervals until NRS rest score < 3 or NRS evoked score < 4.
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of pain
Time Frame: 24 hours postoperatively
The severity of pain will be assessed postoperatively using a numeric rating scale (NRS) both at rest and evoked (0 = no pain and 10 = worst imaginable pain). NRS will be recorded at 1, 2, 4, 6, 8, 10, 12, and 24 hours postoperatively.
24 hours postoperatively
Time to first request analgesia
Time Frame: 24 hours postoperatively
The time to first request analgesia will be recorded from the end of surgery till the first dose of morphine is administrated.
24 hours postoperatively
Incidence of adverse events
Time Frame: 24 hours postoperatively
Incidence of adverse events such as nausea and vomiting will be recorded.
24 hours postoperatively

Collaborators and Investigators

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

Sponsor

Cairo University

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)

February 15, 2025

Primary Completion (Actual)

February 28, 2026

Study Completion (Actual)

February 28, 2026

Study Registration Dates

First Submitted

February 1, 2025

First Submitted That Met QC Criteria

February 4, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP2311-201-091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of the study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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