Erector Spinae Plane Block Versus Local Wound Infiltration After Modified Radical Mastectomy

November 20, 2025 updated by: tarek abdel hay mostafa, Tanta University

Effect of Erector Spinae Plane Block Versus Local Wound Infiltration on Postoperative Pain After Modified Radical Mastectomy

This randomized prospective double blinded study will aim to evaluate the postoperative analgesic effect of ultrasound guided Erector Spinae plane block and local wound infiltration (drain block) for patients scheduled for modified radical mastectomy surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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 is the most commonly diagnosed cancer worldwide and it represents 1 in 4 cancers diagnosed among women globally. Modified Radical Mastectomy (MRM) is a commonly performed surgery for breast cancer and is associated with moderate-to-severe postoperative pain. Poor postoperative pain management can lead to increased chances of the development of chronic pain. Therefore, adequate postoperative pain management after breast cancer surgery is essential. Regional block for pain management has many advantages in such patients including provision of adequate analgesia, reduced need for opioids, decreased postoperative nausea & vomiting and postoperative pulmonary complications. It also facilitates early ambulation. Thoracic Epidural (TE), paravertebral block (PVB), pectoral nerve I & pectoral nerve II blocks, serratus anterior plane block and erector spinae plan block have been used with good results. In particular, the erector spinae has proven to reduce pain severity and opioid consumption in this group of patients. Further, in meta-analysis, the ESP block was shown to effectively alleviate postoperative pain severity and reduce opioid consumption. In ESP block, local anesthetic is deposited deep to the erector spinae muscle which results in blocking of the ventral and dorsal rami of multiple spinal nerves. The LA diffuses into the paravertebral space and cephalo-caudally and blocks the pain by action on dorsal rami, ventral rami, and lateral cutaneous branches of intercostal nerves. Also, in many situations, a superior postoperative analgesia yet avoiding the detrimental effects of opioids, can be extracted from a simple technique of wound instillation of local anesthetics through surgical drain which provide a satisfactory long opioid free postoperative analgesic period.

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 (Actual)

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.
37

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

Study Locations

  • Egypt
    • El Gharbyia
      • Tanta, El Gharbyia, Egypt, 31111
        • faculty of medicine, Tanta 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

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of Anesthesiology (ASA) physical status I-II
  • scheduled for unilateral Modified radical mastectomy

Exclusion Criteria:

  • Patient refusal.
  • Patient with neurological deficit.
  • Patient with bleeding disorders.
  • Uncooperative patient.
  • Infection at the block injection site.
  • Patients with history of allergy to local anesthetics.
  • Advanced hepatic, cardiac or renal failure.
  • Chronic opioid consumption.
  • Body mass index (BMI)≥ 30 kg m-2
  • Chronic use of gabapentin or pregabalin

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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: Erector Spinae Block
Patients of this group will receive ultrasound guided erector spinae block with injection of (20 ml) of plain bupivacaine 0.25% (max dose 2mg/kg) injected beneath the erector spinae muscle sheath at the level of the fourth transvers process (T4).
Procedure: Erector spinae plane block
patients will be placed in the lateral decubitus position. The ESP block is usually performed at the level of fourth transvers process. The ultrasound probe should be placed in a cephalo-caudal orientation over the midline of the back at the desired level.Under aseptic conditions, the block needle will be inserted in plane at an angle of 30-40° in cranial-to-caudal direction until the tip contacted the T4 transverse process at erector spinae plane. After hydro-dissection with 2-3 mL of isotonic saline solution to confirm the correct needle tip position and after negative aspiration to prevent intra vascular injection or position, (20 ml) of plain bupivacaine 0.25% will be injected deep to the erector spinae muscle.
Active Comparator: Drain block
Patients of this group will receive local wound infiltration (drain block) with injection of (20 ml) of plain bupivacaine 0.25% (max dose 2mg/kg) injected in each surgical drain (pectoral and axillary drains) thereafter, the drains would then clamped for 20 minutes and declamped later on.
Procedure: local wound infiltration
after the surgeon complete the surgery and insert the surgical drains (pectoral and axillary drains) we will inject 20ml of plain bupivacaine 0.25% in each surgical drain, the drains will be clamped for 20 minutes then declamped.
Other Names:
  • drain block

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
total morphine consumption
Time Frame: first postoperative day after modified radical mastectomy surgery
total morphine amount which will be consumed in the first postoperative day
first postoperative day after modified radical mastectomy surgery

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.
Tanta 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)

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.
August 10, 2024

Primary Completion (Actual)

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.
July 1, 2025

Study Completion (Actual)

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.
August 1, 2025

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).
July 29, 2024

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.
July 29, 2024

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.
August 1, 2024

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.
November 25, 2025

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.
November 20, 2025

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.
November 1, 2025

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.
  • pain after mastectomy

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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