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

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.

Study Overview

• Status: Completed
• Conditions: Pain Management; Dexmedetomidine; Erector Spinae Plane Block; Ultrasound; Mastectomy; Serratus Anterior Plane Block; Bupivacaine
• Intervention / Treatment: Drug: Bupivacaine + Dexmedetomidine; Drug: Bupivacaine + Dexmedetomidine

Detailed Description

Approximately 40-60% of breast surgery patients endure severe acute postoperative pain, with over 10% of patients experiencing severe pain for six to twelve months (post-mastectomy pain syndrome).

Dexmedetomidine has analgesic properties, which could be related to the stimulation of α2 adrenoceptors, inhibition of nerve conduction through C and Aδ fibers, and the local release of encephalin.

Serratus plane block (SPB) is an effective approach for breast surgery analgesia due to its simplicity of delivery, minimal risk of adverse effects, and ability to provide significant pain relief.

The erector spinae plane block (ESPB) is one of the emerging regional techniques for managing postoperative pain. ESPB can be given unilaterally during modified radical mastectomy.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr Ash Shaykh, Kafrelsheikh, Egypt, 33516
      • Kafrelsheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Serratus anterior plane block group; 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; Patients received serratus anterior plane block on the operated side with bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.; Other Names: Serratus anterior plane block; Drug: Bupivacaine + Dexmedetomidine; 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.; Other Names: Erector spinae plane block
Experimental: Erector spinae plane block group; 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; Patients received serratus anterior plane block on the operated side with bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.; Other Names: Serratus anterior plane block; Drug: Bupivacaine + Dexmedetomidine; 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.; Other Names: Erector spinae plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative fentanyl consumption	In case the cruel blood vessel weight (Outline) or heart rate (HR) went over 20% of pattern values, additional bolus dosages of 0.5 µg/kg IV fentanyl were given.	Intraoperatively
Heart rate	Heart rate was measured preoperatively and intraoperatively every 15 minutes until the end of the surgery.	Every 15 minutes until the end of the surgery (Up to 2 hours)
Mean arterial pressure	Mean arterial pressure was measured preoperatively and intraoperatively every 15 minutes until the end of the surgery.	Every 15 minutes until the end of the surgery (Up to 2 hours)
Degree of pain	Each patient was instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS was assessed at post anesthesia care unit, 1, 2, 6, 12, 18, and 24 hours postoperatively	24 hours postoperatively
Incidence of complications	Incidence of complications such as hypotension, bradycardia, and postoperative nausea and vomiting (PONV) were recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Bupivacaine; Dexmedetomidine
• Other Study ID Numbers: KFSIRB200-438

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: 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