Preemptive Erector Spinae Plane Block Versus Serratus Anterior Plane Block in MRM

Comparison Between Preemptive Erector Spinae Plane Block Versus Serratus Anterior Plane Block on Postoperative Analgesia for Patients Undergoing Modified Radical Mastectomy: A Randomized Clinical Trial

Modified radical mastectomy (MRM) is one of the most performed surgeries for breast cancer. MRM is associated with significant pain during the immediate postoperative period.

Study Overview

• Status: Completed
• Conditions: Modified Radical Mastectomy
• Intervention / Treatment: Procedure: Erector spinae plane group; Procedure: Serratus anterior plane group

Detailed Description

Modified radical mastectomy (MRM) is one of the most performed surgeries for breast cancer. MRM is associated with significant pain during the immediate postoperative period.

Inadequate pain management has both psychological and physiological repercussions.

Various local or regional nerve blocks like thoracic epidural, interscalene brachial plexus, paravertebral, pectoral nerve blocks, and erector spinae plane blocks are performed in MRM to provide analgesia.

Ultrasound-guided Erector spinae plane block (USG-ESPB) is one of the novel and effective regional techniques where local anaesthetic is deposited deep into the erector spinae muscle, blocking the ventral and dorsal rami of multiple spinal nerves, and is technically simple, with fewer hemodynamic side effects and with minimal complications

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Banha, Egypt, 13511
    • Benha University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• female patients
• aged from 18 to 70 years
• with a body mass index ≤ 30 kg/ m2
• American Society of Anesthesiologists (ASA) physical status I-II,
• who were scheduled for MRM for breast cancer

Exclusion Criteria:

• history of drug allergy,
• psychiatric illness, substance abuse,
• severe cardiovascular or respiratory disease,
• any pre-existing liver disease, metabolic or neurological syndrome, c

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erector spinae plane group; The patients were placed in lateral decubitus position with the operation site up. The probe was placed vertically 3 cm lateral to the T5 spinous process, and the transverse process was identified as an oval hyperechoic sonographic structure. The needle was introduced in an in-plane fashion until the tip lay deep in the erector spinae muscle. 0.5 mL of normal saline was injected to confirm the correct needle tip position by visualizing the spread under the erector spinae muscle. A total of 0.4 mL kg-1 of 0.25% bupivacaine was injected. between the erector spinae muscle and transverse process.	Procedure: Erector spinae plane group; The patients were placed in lateral decubitus position with the operation site up. The probe was placed vertically 3 cm lateral to the T5 spinous process, and the transverse process was identified as an oval hyperechoic sonographic structure. The needle was introduced in an in-plane fashion until the tip lay deep in the erector spinae muscle. 0.5 mL of normal saline was injected to confirm the correct needle tip position by visualizing the spread under the erector spinae muscle. A total of 0.4 mL kg-1 of 0.25% bupivacaine was injected. between the erector spinae muscle and transverse process.; Other Names: US ESPB group
Experimental: Serratus anterior plane group; Serratus anterior plane block was administered to patient in the supine position with ipsilateral arm abducted to 90°. Under aseptic precautions, linear probe was placed over the midclavicular region in the sagittal plane. Ribs were counted inferiorly and laterally until the fifth rib was identified in midaxillary line. Latissimus dorsi, teres major, and serratus anterior muscles were identified overlying the fifth rib. The intended puncture site was infiltrated with 2 mL of 2% lignocaine, and using ultrasound-guided in-plane approach, the needle was introduced in caudal to cranial direction until the tip was placed between the serratus anterior muscle and external intercostal muscle.	Procedure: Serratus anterior plane group; Serratus anterior plane block was administered to patient in the supine position with ipsilateral arm abducted to 90°. Under aseptic precautions, linear probe was placed over the midclavicular region in the sagittal plane. Ribs were counted inferiorly and laterally until the fifth rib was identified in midaxillary line. Latissimus dorsi, teres major, and serratus anterior muscles were identified overlying the fifth rib. The intended puncture site was infiltrated with 2 mL of 2% lignocaine, and using ultrasound-guided in-plane approach, the needle was introduced in caudal to cranial direction until the tip was placed between the serratus anterior muscle and external intercostal muscle.; Other Names: USAPB group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of the first rescue analgesic dose	The time when the first dose of rescue analgesia was administered at the recovery room,	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate changes	Heart rate (HR) was recorded immediately before induction of anaesthesia, 1	15 minutes after performing the block, and then every 30 minutes intraoperatively till the end of surgery, then postoperatively at 1hour and 2 hours, 4hours, 8hours, 12hours, 18hours, 24hours postoperatively.
Mean arterial pressure changes	Mean arterial pressure	15 minutes after performing the block, and then every 30 minutes intraoperatively till the end of surgery, then postoperatively at 1hour and 2 hours, 4hours, 8hours, 12hours, 18hours, 24hours postoperatively.

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Ramy Saleh, MD, Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2023
• Primary Completion (Actual): February 22, 2024
• Study Completion (Actual): April 3, 2024

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 4, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Erector Spinae Plane Block; Serratus Anterior Plane Block
• Other Study ID Numbers: RC 23-11-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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