Ultrasound-guided Pectoral Nerve Blocks, Thoracic Erector Spinae Plane Block and Serratus Anterior Plane Block for Breast Surgery

Comparison Between Ultrasound-guided Pectoral Nerve Blocks, Thoracic Erector Spinae Plane Block and Serratus Anterior Plane Block for Breast Surgery: A Prospective Randomized Study

The study will compare ultrasound-guided Pectoral nerve block, Erector Spinae Plane block, and Serratus anterior plane block for pain management following elective breast surgeries

Study Overview

• Status: Recruiting
• Conditions: Breast Surgery; Ultrasound; Serratus Anterior Plane Block; Thoracic Erector Spinae Plane Block; Pectoral Nerve Blocks
• Intervention / Treatment: Drug: Pectoral nerve block (PECS); Drug: Erector spinae plane block (ESP); Drug: Serratus anterior plane block (SAP)

Detailed Description

Adequate acute postoperative pain control is important for patients undergoing breast surgery because the pain may be severe and longlasting. Surgical incision at the breast and axillary areas is associated with significant pain, with high incidence of acute pain progressing to chronic pain in 25% to 60% of patients. Post-mastectomy pain managed with opioids often lead to side effects of nausea and vomiting.

Regional anesthetic techniques are used in the current management of pain associated with breast surgeries .They attenuate surgical stress response , intraoperative consumption of opioid, prevent central sensitization and diminish postoperative pain.

The efficacy of fascial plane blocks like pectoral nerve block (PECS), serratus anterior plane block (SAP), and erector spinae plane block (ESP) has been proven in previous studies. These blocks require deposition of local anesthetic in an inter-fascial plane through which peripheral nerves travel.

The Pectoral nerve block relies upon the deposition the local anesthetic at the inter-fascial planes among the pectoralis major, minor, and serratus anterior muscles: it blocks the pectoral, the intercostobrachial, the intercostals III and VI, and the long thoracic nerves.

Erector Spinae Plane block is another interfacial plane block. It involves deposition of local anesthetic between erector spinae muscle and transverse process of T5 vertebrae and targets both dorsal and ventral rami of thoracic spinal nerves.

Serratus anterior plane block involves the injection of local anesthetic in 1 of the 2 fascial planes, superficial and deep to serratus anterior muscle at the level of the fifth rib in midaxillary line. The SAP block targets the lateral cutaneous branches of the thoracic intercostal nerves. The deep SAP block was found to have similar analgesic efficacy and technically easier and safer to perform as compared to the superficial SAP block.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rehab S Taha, Master; Phone Number: 00201000507975; Email: rehabsalah2017@gmail.com

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Sub-Investigator: Sabry M Amin, MD
      • Contact: Rehab S Taha, Master; Phone Number: 00201000507975; Email: rehabsalah2017@gmail.com
      • Sub-Investigator: Ashraf E Alzftawy, MD
      • Sub-Investigator: Attia G Ibrahim, MD
      • Sub-Investigator: Nashwa E Hamoda, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age from 21 to 65 years old female, American Society of Anesthesiologists (ASA) physical status I or II, who will undergo breast surgeries under general anesthesia.

Exclusion Criteria:

• Patient refusal to participate in research.
• Body Mass Index (BMI) ≥35 kg/m2.
• Sensitivity to the intervention drugs.
• Coagulation abnormalities.
• Psychiatric disorder and communication difficulties.
• Chronic neurological disease.
• Any skin infection at the needle puncture site.
• Chest wall deformity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pectoral nerve block (PECS); Patients will receive pectoral nerve block (PECS).	Drug: Pectoral nerve block (PECS); Patients will receive pectoral nerve block (PECS).; Other Names: Bupivacaine 0.25
Experimental: Erector spinae plane block (ESP); Patients will receive erector spinae plane block (ESP).	Drug: Erector spinae plane block (ESP); Patients will receive erector spinae plane block (ESP).; Other Names: Bupivacaine 0.25
Experimental: Serratus anterior plane block (SAP); Patients will receive serratus anterior plane block (SAP).	Drug: Serratus anterior plane block (SAP); Patients will receive serratus anterior plane block (SAP).; Other Names: Bupivacaine 0.25

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption	Rescue analgesia of morphine will be given as 3 mg bolus if the visual analogue scale (VAS) ≥ 4 to be repeated after 30 min if pain persists until the VAS< 4.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the 1st rescue analgesia	Time to 1st request for the rescue of analgesia (time from the end of surgery till first dose of morphine administrated) will be recorded.	24 hours postoperatively
Intraoperative fentanyl consumption	Intraoperative fentanyl consumption will be recorded.Additional fentanyl bolus dosages of 0.5 µg/kg IV will be administered if mean arterial blood pressure and heart rate elevated more than 20% of the baseline (after exclusion of other causes).	Intraoperatively
Pain degree	Each patient will be instructed about postoperative pain assessment with the visual analogue scale (VAS) (20), from 0 to 10 (0 represents "no pain" while 10 represents "the worst pain imaginable").Rescue analgesia of morphine will be given as 3 mg bolus if the VAS ≥ 4 to be repeated after 30 min if pain persists until the VAS< 4. VAS will be assessed at 30min, 2, 6,12 and 24 h postoperatively	24 hours postoperatively
Mean arterial blood pressure	Intraoperative hemodynamic parameters: Mean arterial blood pressure (MAP) will be recorded at baseline, after performing of block, and every 15 min till the end of surgery.	Till the end of surgery (Up to 24hours)
Heart rate	Intraoperative hemodynamic parameters: Heart rate (HR) will be recorded at baseline, after performing of block, and every 15 min till the end of surgery.	Till the end of surgery (Up to 24hours)
Patient satisfaction	Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)	24 hours Postoperatively
Adverse effects	bradycardia, hypotension, nausea, vomiting, respiratory depression, hematoma at the site of injection, local anesthetic toxicity will be recorded.	24 hours Postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: April 20, 2025
• First Submitted That Met QC Criteria: April 20, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: 36265MD276/9/24

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.

Drug and device information, study documents

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