Serratus Anterior Plane Block Versus Erector Spinae Plane Block With Dexmedetomidine Added to Bupivacaine for Ultrasound-Guided Pain Management After Mastectomy

NCT06737458 | Completed

• 1 other identifier: KFSIRB200-438
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the serratus plane block versus the erector spinae plane block with dexmedetomidine added to bupivacaine for acute pain management after breast surgeries.

Conditions

Serratus Anterior Plane Block; Erector Spinae Plane Block; Dexmedetomidine; Bupivacaine; Ultrasound; Pain Management; Mastectomy

Outcome Measures

Primary Outcomes (1)

• Total dose of pethidine consumption

  Patients get 1 g paracetamol IV like clockwork. Salvage absence of pain as bolus IV pethidine at 0.5 mg/kg was managed if NRS \> 3

  24 hours postoperatively

Secondary Outcomes (5)

• Intraoperative fentanyl consumption

  Intraoperatively

• Heart rate

  Every 15 minutes until the end of the surgery (Up to 2 hours)

• Mean arterial pressure

  Every 15 minutes until the end of the surgery (Up to 2 hours)

• Degree of pain

  24 hours postoperatively

• Incidence of complications

  24 hours postoperatively

Study Arms (2)

Serratus anterior plane block group

ACTIVE COMPARATOR

Patients received serratus anterior plane block on the operated side with bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.

Drug: Bupivacaine + Dexmedetomidine

Erector spinae plane block group

EXPERIMENTAL

Patients received erector spinae plane block at T5 on the operated side and will receive bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.

Drug: Bupivacaine + Dexmedetomidine

Interventions

Bupivacaine + Dexmedetomidine DRUG

Patients received serratus anterior plane block on the operated side with bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.

Also known as: Serratus anterior plane block

Serratus anterior plane block group

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Female patients underwent breast surgeries.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged \>20 years.
• Patient's approval.
• American Society of Anesthesiologists (ASA) physical status I-II.
• Patients underwent breast surgeries.

You may not qualify if:

• Known allergy to local anesthetics, opioids, or dexmedetomidine medications.
• Advanced heart block, ventricular dysfunction.
• Skin infection at the site of injection.
• Pre-existing chronic pain.
• Coagulopathies, significant liver or renal insufficiency.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelshiekh University, Kafrelshiekh, Egypt

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)