Actively Recruiting

Phase 3
Age: 21Years - 65Years
FEMALE
ID06947330

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

Led by Kholoud Usama · Updated on 2025-04-27

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare two types of ultrasound-guided nerve blocks, the Erector Spinae Plane Block (ESPB) and the Serratus Anterior Plane Block (SAPB), in adult women undergoing Modified Radical Mastectomy for breast cancer. The study evaluates which block provides better pain relief and which is safer regarding risks like pneumothorax and hemodynamic changes. Both methods are being assessed to improve postoperative pain management after breast surgery. Participants will be randomly assigned to receive either the ESPB or SAPB block after anesthesia but before surgical incision. Each block involves injecting a combination of bupivacaine and dexmedetomidine guided by ultrasound to target specific nerve areas. Lung ultrasound will be performed before and after surgery to check for pneumothorax. Those who develop pneumothorax will be excluded and treated accordingly. The study includes a 24-hour follow-up period to monitor pain levels and additional pain medication use. During the study, participants will have their pain measured at multiple time points up to 24 hours after surgery using the Visual Analog Score (VAS). Researchers will also track total pain medication doses, duration of analgesia, vital signs, and the occurrence of pneumothorax. The study uses a double-blind design to ensure unbiased results. Overall participation spans the surgery day and the first postoperative day for close monitoring and data collection.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 21Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA Physical Status II, or III.
  • Age 21 - 65 years.
  • Female gender
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day and immediate postoperative period

Participants undergo modified radical mastectomy surgery with either Erector Spinae Plane Block or Serratus Anterior Plane Block for postoperative pain management.

1 surgical visit and assessments during hospital stay up to 24 hours postoperatively

Post-operative Follow-up

Duration - 24 hours postoperatively

Participants are monitored for pain levels, analgesic use, vital signs, and possible complications such as pneumothorax during the 24 hours following surgery.

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

Trial Site Locations

Total: 1 location

1

Faculty of Medicine, Ain-Shams University

Cairo, Waili, Egypt, 0000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Comparison Between Erector Spinae Plane Block versus Serratus Anterior Plane Block Regarding Analgesia and Stress Response After Modified Radical Mastectomy: Randomized Controlled Trial.

Ahmed Abd Elmohsen Bedewy, Maged Salah Mohamed, Hesham Mohamed Sultan...

https://pubmed.ncbi.nlm.nih.gov/38741901