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

NCT06947330 | Recruiting Phase 3 DMC

• 1 other identifier: FMASU-MD66/2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Modified Radical Mastectomy; Breast Cancer

Keywords

Breast Cancer; Modified Radical Mastectomy; Peripheral Nerve Block; Dexmedetomidine; Erector Spinae Plane Block; Serratus Anterior Plane Block; Ultrasound Guided; Adult Female

Outcome Measures

Primary Outcomes (1)

• Visual Analog Score for pain

  * 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 Outcomes (4)

• Total dose of pethidine in mg.

  at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively

• Duration of analgesia postoperatively in hours.

  at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively

• Rate of vital data changes over the postoperative period

  every 2 hour during the first 6 hours and then every 6 hours for 24 hours postoperatively.

• Incidence of pneumothorax

  Intra-operatively

Study Arms (2)

Unilateral Erector Spinae group

ACTIVE COMPARATOR

-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

Unilateral Serratus Anterior group

ACTIVE COMPARATOR

-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

Interventions

Unilateral Erector Spinae group PROCEDURE

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.

Also known as: Peripheral Nerve Block using Precedex, Erector Spinae block with Precedex as an adjuvant drug

Unilateral Erector Spinae group

Unilateral Serratus Anterior group PROCEDURE

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.

Also known as: Peripheral Nerve Block using dexmedetomidine, Serratus Anterior Block with dexmedetomidine as an adjuvant drug

Unilateral Serratus Anterior group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kholoud Usama: lead

Study Sites (1)

Faculty of Medicine, Ain-Shams University

Cairo, Waili, 0000, Egypt

RECRUITING

Related Publications (2)

• Chen Z, Liu Z, Feng C, Jin Y, Zhao X. Dexmedetomidine as an Adjuvant in Peripheral Nerve Block. Drug Des Devel Ther. 2023 May 17;17:1463-1484. doi: 10.2147/DDDT.S405294. eCollection 2023.

  PMID: 37220544 BACKGROUND

• Abd Elmohsen Bedewy A, Mohamed MS, Sultan HM, Khalil MS. Comparison Between Erector Spinae Plane Block versus Serratus Anterior Plane Block Regarding Analgesia and Stress Response After Modified Radical Mastectomy: Randomized Controlled Trial. Anesth Pain Med. 2024 Mar 26;14(2):e142189. doi: 10.5812/aapm-142189. eCollection 2024 Apr.

  PMID: 38741901 BACKGROUND

Related Links

• Kumar, M.N., Begum, B.S. and R. Iniya (2022). A prospective randomized comparative study on erector spinae plane block and serratus anterior plane block in the postoperative pain management after breast surgeries. International Journal of Health Sciences
• Gola, W., Białka, S., Andrzejewska, A., Palaczynski, P. and Misiołek, H. (2022). Fascial plane blocks for breast surgery - current state of knowledge. Anaesthesiology Intensive Therapy, \[online\] 54(3), pp.262-270.
• Mangold, M.S., Rüber, F., Steinack, C., Gautschi, F., Wani, J., Grimaldi, S. and Franzen, D.P. (2023). Lung Ultrasound for the Exclusion of Pneumothorax after Interventional Bronchoscopies-A Retrospective Study. Journal of Clinical Medicine, \[online\] 12(
• Muhammad, Q.U.A., Sohail, M.A., Azam, N.M., Bashir, H.H., Islam, H., Ijaz, R., Aquil, S., Mansoor, T., Dhakal, B., Fatima, T., Noor, J., Khan, A.S., Iqbal, A., Khatri, M. and Kumar, S. (2024). Analgesic efficacy and safety of erector spinae versus serrat
• Nair, A., \&Diwan, S. (2022). Efficacy of ultrasound-guided serratus anterior plane block for managing pain due to multiple rib fractures: a scoping review. Cureus, 14(1).
• Ülgey, A., Pehlivan, S. S., \&Demir, Ö. F. (2021). Postoperative thoracic pain treatment: serratus anterior or erector spinae plane block?. The Thoracic and Cardiovascular Surgeon, 69(06), 570-576.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: Sampling method will be simple random. Patients will be randomly assigned into one of the following groups using opaque sealed envelopes: 1. Group A (50 patients); will receive ultrasound guided Erector Spinae Plane Block. 2. Group B (50 patients); will receive ultrasound guided Serratus Anterior Plane Block.

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: April 27, 2025
• Study Start: March 3, 2025
• Primary Completion: March 3, 2026
• Study Completion: March 4, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)