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

NCT06404918 | Completed

• 1 other identifier: RC 23-11-2023
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Modified Radical Mastectomy

Keywords

Erector Spinae Plane Block; Serratus Anterior Plane Block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Heart rate changes

  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

  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.

Study Arms (2)

Erector spinae plane group

EXPERIMENTAL

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

Serratus anterior plane group

EXPERIMENTAL

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

Interventions

Erector spinae plane group PROCEDURE

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.

Also known as: US ESPB group

Erector spinae plane group

Serratus anterior plane group PROCEDURE

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.

Also known as: USAPB group

Serratus anterior plane group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, 13511, Egypt

Location

Study Officials

• Ramy Saleh, MD

  Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The patients and Care Provider in this trial were blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Group I (35 patients): patients received US ESPB and group II (35 patients): patients received USAPB.

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 8, 2024
• Study Start: January 22, 2023
• Primary Completion: February 22, 2024
• Study Completion: April 3, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)