Adding Magnesium Sulphate to Combined Pectointercostal Plane and Erector Spinae Plane Blocks for Acute and Chronic Post-Mastectomy Pain

February 22, 2026 updated by: Mohammed Farghaly Abd El hamid Ahmed, South Egypt Cancer Institute

Efficacy of Adding Magnesium Sulphate to Combined Pectointercostal Plane Block and Erector Spinae Plane Block for Acute and Chronic Post-Mastectomy Pain After Modified Radical Mastectomy. A Controlled Clinical Trial

Given the burden of chronic postmastectomy pain and the need for effective, opioid-sparing analgesia, the propose of the randomized controlled trial is to evaluate the safety and efficacy of adding magnesium sulphate to the combination of PIP block and ESPB in patients undergoing modified radical mastectomy for reducing acute and chronic post mastectomy pain

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Breast cancer remains one of the most common malignancies worldwide, and modified radical mastectomy (MRM) continues to be a mainstay surgical treatment in many cases. However, postoperative pain after MRM can be significant, both in the acute period and long-term, contributing to persistent pain syndromes, impaired recovery, and reduced quality of life. Regional anesthesia techniques such as the pectointercostal plane (PIPB) block and erector spinae plane block (ESPB) have gained wide acceptance as effective approaches to reduce perioperative analgesic requirements, improve pain control, and potentially mitigate chronic post-surgical pain. Magnesium sulphate (MgSO4 ) is increasingly studied as an adjuvant in regional anesthesia, owing to its NMDA-receptor antagonism, calcium channel modulation, and possible anti-inflammatory effects. Meta-analyses in peripheral nerve blocks, such as supraclavicular brachial plexus block, have demonstrated that adding MgSO4 prolongs sensory and motor blockade, delays the need for rescue analgesia, and is generally well tolerated. Moreover, in abdominal surgery, MgSO4 added to bupivacaine in a transversus abdominis plane (TAP) block significantly reduced postoperative pain scores and extended analgesia duration. Erector spinae plane block is particularly attractive in mastectomy because it provides extensive dorsal and lateral thoracic analgesia. Beyond ESPB and Pectointercostal Plane Block, other interfascial plane blocks in breast surgery have also shown benefit with magnesium. Such consistent results across different block techniques support the hypothesis that magnesium enhances regional anesthesia outcomes in breast surgery.

Despite this promising data, there remain gap. No study has yet, concurrently evaluated magnesium as an adjuvant to both PIP block and ESPB in the same patient population, nor assessed its effects on both acute postoperative pain and the development of chronic postoperative pain.

So, the aim of this randomized controlled trial is to evaluate the safety and efficacy of adding magnesium sulphate to the combination of PIP block and ESPB for reducing acute and chronic post mastectomy pain in patients undergoing modified radical mastectomy.

A randomized controlled double-blinded study will be conducted in South Egypt Cancer Institute, Assiut University, after approval from the Institutional Ethics Committee.

Primary outcome:

Time to first rescue analgesia.

Secondary outcomes:

Total opioid consumption (morphine equivalent) in the first 24 hours postoperatively.

Postoperative pain scores (VAS) at rest and movement. Incidence of postoperative nausea and vomiting. Block-related complications. Incidence and severity of chronic post mastectomy pain.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: bahaa ga saad, lecturer
  • Phone Number: 01003644592

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients aged ≥18 years.
  • American Society of Anesthesiologists (ASA) class I-III.
  • Scheduled for unilateral modified radical mastectomy.

Exclusion Criteria:

  • Known allergy to local anesthetics or magnesium.
  • Coagulopathy or anticoagulant therapy.
  • Local infection at injection site.
  • Body mass index (BMI) ≥ 40 kg/m2.
  • Chronic opioid use or chronic pain disorders.
  • Neurological or psychiatric disorders affect pain perception.
  • Severe hepatic or renal impairment.
  • Pregnancy.
  • Lactation.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group M (Magnesium Group)

Patients will receive the combined PIP and ESP blocks using bupivacaine + magnesium sulphate.

  • 20 mL of 0.25% bupivacaine + 150 mg magnesium sulphate diluted to5 ml (in each block).
  • 150 mg with each block (total magnesium dose = 300 mg).
Procedure: Pectointercostal Plane Block (PIPB)
A high-frequency linear ultrasound probe will be placed at the level of the 2nd-3rd rib, medial to the pectoralis major muscle. The pectointercostal fascial plane located between the pectoralis major muscle and the external/internal intercostal muscles will be identified. Under in plane ultrasound guidance, the needle will be advanced into this plane, and the study drug will be administered. All patients will receive 20 mL of 0.25% bupivacaine; however, patients in Group M will additionally receive magnesium sulphate 150 mg diluted to 5 mL, which will be injected into the same plane.
Other Names:
  • (PIPB)
Procedure: Erector Spinae Plane Block (ESPB)
For this block, the patient will be positioned laterally. The ultrasound probe will be placed at the T3-T5 vertebral level to visualize the transverse process. An in- plane technique will be used to advance the needle into the deep fascial plane beneath the erector spinae muscle. Once the correct position is confirmed, 20 mL of 0.25% bupivacaine will be injected, with Group M patients receiving an additional 150 mg of magnesium sulphate diluted to 5 mL. The total magnesium dose administered in Group M will be 300 mg. Negative aspiration will be performed prior to each injection to avoid intravascular administration.
Other Names:
  • (ESPB):
Drug: Magnesium sulfate
All patients will receive 20 mL of 0.25% bupivacaine; however, patients in Group M will additionally receive magnesium sulphate 150 mg diluted to 5 mL, which will be injected into the same plane. The total magnesium dose administered in Group M will be 300 mg
Sham Comparator: Group C (Control Group)
Patients will receive the combined PIP and ESP blocks using bupivacaine only (20 ml of 0.25% bupivacaine)
Procedure: Pectointercostal Plane Block (PIPB)
A high-frequency linear ultrasound probe will be placed at the level of the 2nd-3rd rib, medial to the pectoralis major muscle. The pectointercostal fascial plane located between the pectoralis major muscle and the external/internal intercostal muscles will be identified. Under in plane ultrasound guidance, the needle will be advanced into this plane, and the study drug will be administered. All patients will receive 20 mL of 0.25% bupivacaine; however, patients in Group M will additionally receive magnesium sulphate 150 mg diluted to 5 mL, which will be injected into the same plane.
Other Names:
  • (PIPB)
Procedure: Erector Spinae Plane Block (ESPB)
For this block, the patient will be positioned laterally. The ultrasound probe will be placed at the T3-T5 vertebral level to visualize the transverse process. An in- plane technique will be used to advance the needle into the deep fascial plane beneath the erector spinae muscle. Once the correct position is confirmed, 20 mL of 0.25% bupivacaine will be injected, with Group M patients receiving an additional 150 mg of magnesium sulphate diluted to 5 mL. The total magnesium dose administered in Group M will be 300 mg. Negative aspiration will be performed prior to each injection to avoid intravascular administration.
Other Names:
  • (ESPB):

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to first rescue analgesia.
Time Frame: 24 hours postoperatively
Rescue analgesia of morphine will be given as 3 mg bolus if the VAS > 3 to be repeated after 30 min if pain persists until the VAS < 4.
24 hours postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total opioid consumption .
Time Frame: 24 hours postoperatively
Total opioid consumption (morphine equivalent) in the first 24 hours postoperatively
24 hours postoperatively
Postoperative pain scores (VAS)
Time Frame: 24 hours postoperatively
Postoperative pain scores (VAS) at rest and movement where 0= no pain, 10= worst imaginable pain
24 hours postoperatively

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
South Egypt Cancer Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Assiut 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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-2026-811
  • 811 (Registry Identifier: IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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Conditions

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