Comparison Between Erector Spinae Plane Block Versus Serratus Anterior Plane Block Regarding Analgesia Post Modified Radical Mastectomy (FMASUMD66/2025)

April 20, 2025 updated by: Kholoud Usama

Comparison Between Ultrasound Guided Erector Spinae Plane Block Versus Ultrasound Guided Serratus Anterior Plane Block Regarding Analgesia Post Modified Radical Mastectomy

The goal of this clinical trial is to compare Ultrasound Guided Erector Spinae and Ultrasound Guided Serratus Anterior Plane Block post Modified Radical Mastectomy in adult females. the main questions it aims to answer are:

  • Which of the two blocks has a better analgesic effect?
  • Which of the two blocks is safer as regards inducing a pneumothorax and affecting the hemodynamics?

Participants:

  • Will be divided into two groups after signing the informed consent.
  • After being anesthetized and before surgical incision; the blocks will be given to the patient.
  • Lung Ultrasound will be done for each patient to rule out pnemothorax once before the surgery and another after the end of surgery while the patient is being anesthetized.
  • Patients that will experience pneuomothorax will be excluded from the study, and will be treated according to its size.
  • Follow up of the patient for 24 hours postoperative to record the VAS score continuously, with giving increments of pethidine intravenously to relief pain.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast surgeries belong to the most frequently performed procedures and are often associated with a high intensity of pain in the postoperative period.

Regional anesthesia techniques, have been the gold standard of postoperative pain management for breast surgeries. In recent years, the development of new techniques of regional anesthesia, which is due to the extensive implementation of ultrasound imaging, has enabled the use of a number of new blockades.The core mechanism of action in fascial blocks consists of blocking the nerve structures that supply a certain area of the trunk after deposition of local anesthetic within the fascial and fasciomuscular compartments. According to the current state of knowledge, the available options include Erector spinae plane block (ESPB) and Serratus anterior plane block (SAPB), however their recommendation in breast surgery requires more extensive scientific evidence.

Serratus anterior plane block acts on lateral branches of the intercostals nerves, blocking pain reception in the chest wall, while Erector spinae plane block involves the deposition of local anesthetic in the interfascial plane between erector spinae muscle and tips of the transverse processes of the vertebrae.

There is a scarcity of literature comparing ESPB and SAPB in patients undergoing breast surgeries.

Proponents of these techniques champion their ability to provide efficacious analgesia and anesthesia whereas critics cite a reportedly high failure rate and complications such as pneumothorax.

The German S3-guidelines suggest Lung Ultrasound as a possible alternative to Chest X-ray for the diagnosis of post-interventional pneumothorax.

Dexamedetomidine is a highly selective drug α2-adrenergic receptor agonist. Dexmedetomidine has the characteristics of sedation, analgesia, anti-anxiety, inhibition of sympathetic activity, mild respiratory inhibition, and stable hemodynamics. Numerous studies has revealed that dexmedetomidine in peripheral nerve blocks can shorten the onset time of anesthesia and prolong the time of sensory and motor nerve blocks.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

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
    • Waili
      • Cairo, Waili, Egypt, 0000
        • Recruiting
        • Faculty of Medicine, Ain-Shams University
        • Contact:
        • Contact:
          • Amir Ibrahim Mohamed Salah, Doctorate degree, Professor
        • Contact:
          • Randa Ali Shoukry Mohamed, Doctorate degree, Professor
        • Contact:
          • Sanaa Mohamed Mohamed Elfawal, Doctorate degree, Professor
        • Contact:
          • Mohamed Ibrahim Ibrahim Sobhy, Doctorate degree, Lecturer

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:

  • ASA Physical Status II, or III.
  • Age 21 - 65 years.
  • Female gender

Exclusion Criteria:

  • ASA IV, V, VI.
  • Infection at site of block.
  • Coagulopathy, or patients on antiplatelets, or anticoagulants.
  • Previous anesthetic allergy to bupivacaine.
  • Distant organ metastasis.
  • Male gender.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Unilateral Erector Spinae group
-The patient will be turned to the lateral decubitus position and the surgical side superiorly. After proper sterilization; The linear probe will be put in a parasagittal plane over the transverse process of thoracic 4 or thoracic 5 vertebrae, approximately 2.5 cm lateral to the spinous processes. The transverse process has a square form contour as compared to the rib which is rounded form contour. Then the 3 muscle layers or sheets with facial plane are distinguished from superficial to deep as trapezius, rhomboid major, and erector spinae with flickering pleura in between the transverse processes. The block will be managed unilaterally by in-plane technique using 22-gauge, 50 mm, echogenic needle which will be inserted in a cranial-caudal orientation and the block needle will be proceeded through the trapezius, rhomboid major, and erector spinae to smoothly contact the transverse process. Needle location will be confirmed by hydro-dissection on injecting 2-3 ml normal saline.
Procedure: Unilateral Erector Spinae group
On injecting 30 ml of bupivacaine 0.25% with 20 mcg Dexamedetomidine into the interfacial plane below erector spinae; a manifest linear pattern will be visualized uplifting the muscle.
Other Names:
  • Peripheral Nerve Block using Precedex
  • Erector Spinae block with Precedex as an adjuvant drug
Active Comparator: Unilateral Serratus Anterior group
-After skin sterilization, with the patient in the lateral decubitus position and the side of surgery superiorly, the ultrasound linear probe will be put longitudinally oblique just below the mid-clavicle. After distinguish the second rib, the probe will be mobilized caudally and laterally (obliquely), towards the mid-axillary line to distinguish the third, fourth and fifth ribs. The ideal and definite probe position has its cephalad end at the anterior axillary line and the caudal end at the posterior axillary line. The facial plane between the serratus anterior muscle and ribs four and five will be identified between the 4th and 5th rib in the mid-axillary region. Under sonar guided, 50 mm echogenic needle will be advanced in-plane to introduce this facial plane in cranio-caudal direction.
Procedure: Unilateral Serratus Anterior group
Once the needle will be in perfect position, confirmed by hydro-dissection on injecting 2-3 ml of normal saline, then 30 ml of bupivacaine 0.25% with 20 mcg Dexamedetomidine.
Other Names:
  • Peripheral Nerve Block using dexmedetomidine
  • Serratus Anterior Block with dexmedetomidine as an adjuvant drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Score for pain
Time Frame: at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively
  • After extubation, the patient will be discharged from the operating room. VAS will be used to assess the postoperative pain (Myles et al., 2017).
  • Visual analogue scale score:

Grade 0 (0-1 units on a scale): Good analgesia. Grade I (2-4 units on a scale): Moderate analgesia Grade II (5-7 units on a scale): Mild analgesia Grade III (8-10 units on a scale): No analgesia.

  • If VAS >3 units on a scale postoperatively, IV increment of pethidine 30 mg diluted in 5 ml saline will be given.
  • VAS ranging from (0 units on a scale) no pain, to (10 units on a scale) severe intolerable pain;
at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total dose of pethidine in mg.
Time Frame: at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively
If VAS >3 units on a scale postoperatively, IV increment of pethidine 30 mg diluted in 5 ml saline will be given.
at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively
Duration of analgesia postoperatively in hours.
Time Frame: at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively
If VAS >3 units on a scale postoperatively, IV increment of pethidine 30 mg diluted in 5 ml saline will be given.
at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively
Rate of vital data changes over the postoperative period
Time Frame: every 2 hour during the first 6 hours and then every 6 hours for 24 hours postoperatively.

HR and MBP will be measured upon arrival to the PACU and after 30 min, then every hour if the patients remain in the PACU.

In the surgical ward, vital signs (HR, SBP, MBP, DBP) as well as pain intensity will be assessed every 2 hour during the first 6 hours and then every 6 hours for 24 hours postoperatively.
every 2 hour during the first 6 hours and then every 6 hours for 24 hours postoperatively.
Incidence of pneumothorax
Time Frame: Intra-operatively
  • Measurement tool: Lung ultrasound
  • After giving the block in each group, Lung Ultrasound will be performed on patients in the supine body position. The transducer will be placed longitudinally at the highest point of the anterior thorax, then moved along the intercotal spaces of the parasternal line and laterally, between the anterior and posterior axillary line, checking for lung sliding and lung point in 2D B-mode, and for seashore or stratosphere sign in M-mode. The hemithorax without intervention was examined first and then compared to the hemithorax with intervention.
  • The Lung Ultrasound will be repeated after the end of the surgery, while the patient is anesthetized, and before extubation. Cases of pneumothoraces either large or small will be excluded from the study.
Intra-operatively

Collaborators and Investigators

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

Sponsor

Kholoud Usama

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

March 3, 2025

Primary Completion (Estimated)

March 3, 2026

Study Completion (Estimated)

March 4, 2026

Study Registration Dates

First Submitted

April 13, 2025

First Submitted That Met QC Criteria

April 20, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 20, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU-MD66/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. 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

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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