Efficacy of Serratus Anterior Plane Block With Dexmedetomidine During Breast Surgery

Efficacy of Single Level Versus Bilevel Serratus Anterior Plane Block With Dexmedetomidine During Breast Cancer Surgery

This study aims to compare single level serratus block versus bilevel serratus block with and without dexmedetomidine in cancer patients undergoing modified radical mastectomy for breast cancer regarding pain control and possible side effects.

Study Overview

• Status: Recruiting
• Conditions: Analgesia
• Intervention / Treatment: Procedure: Single level serratus anterior plane block; Procedure: Single level serratus anterior plane block with dexmedetomidine; Procedure: Bilevel serratus anterior plane block; Procedure: Bilevel serratus anterior plane block with dexmedetomidine

• Study Type: Interventional
• Enrollment (Estimated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Walaa Y Elsabeeny, MD; Phone Number: +2 201007798466; Email: walaa.elsabeeny@nci.cu.edu.eg
• Study Contact Backup: Name: Nahla N Shehab, MD; Phone Number: +2 01221682808; Email: nahla.shehab2@gmail.com

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11796
      • Recruiting
      • Walaa Y Elsabeeny
      • Contact: Walaa Y Elsabeeny, MD; Phone Number: +201007798466; Email: walaa.elsabeeny@nci.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients scheduled for modified radical mastectomy,
• Age 18-65 years,
• ASA I-II

Exclusion Criteria:

• patient refusal,
• coagulation defects,
• abnormal kidney or liver functions,
• local infection at site of injection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single level serratus anterior plane block; the allocated patients will receive single injection serratus anterior plane block at the level of third rib with local anesthetics only	Procedure: Single level serratus anterior plane block; Serratus anterior plane block with local anesthetics at the third rib
Experimental: Single level serratus anterior plane block with dexmedetomidine; the allocated patients will receive single injection serratus anterior plane block at the level of third rib with local anesthetics and dexmedetomidine	Procedure: Single level serratus anterior plane block with dexmedetomidine; Serratus anterior plane block with local anesthetics and dexmedetomidine at the third rib
Experimental: Bilevel serratus anterior plane block; the allocated patients will receive injection serratus anterior plane block at 2 levels, the level of third rib and the level of the fifth rib with local anesthetics only	Procedure: Bilevel serratus anterior plane block; Serratus anterior plane block with local anesthetics at the third and fifth rib
Experimental: Bilevel serratus anterior plane block with dexmedetomidine; the allocated patients will receive injection serratus anterior plane block at 2 levels, the level of third rib and the level of the fifth rib with local anesthetics and dexmedetomidine	Procedure: Bilevel serratus anterior plane block with dexmedetomidine; Serratus anterior plane block with local anesthetics and dexmedetomidine at the third and fifth rib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First time to receive analgesia	first time to receive morphine analgesia in hours	First 24 hours postoperatively
Total analgesic requisite	total amount of morphine consumption in the first 24 hours postoperatively in mg	First 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	pain scores will be assessed using Visual Analogue Scale on a sale from 0 to 10 with 0 meanung no pain and 10 meaning severe pain	First 24 hours postoperatively
Side effects	nausea and vomiting and hematoma at site of injection	First 24 hours postoperatively
Perioperative heart rate values	heart rate values in the form of beat per minute in the perioperative period including preoperative, intraoperative and postoperative	First 24 hours
Mean arterial blood pressure	Mean arterial blood pressure values in the form mmHg in the perioperative period including preoperative, intraoperative and postoperative	First 24 hours

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Investigators: Principal Investigator: Walaa Y Elsabeeny, MD, Assistant Professor of Anesthesia and Pain management

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 25, 2026

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 27, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Dexmedetomidine
• Other Study ID Numbers: AP2204-50104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No