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

Not Applicable

Completed

• Conditions: Modified Radical Mastectomy
• Interventions: Procedure: Erector spinae plane group; Procedure: Serratus anterior plane group

• Registration Number: NCT06404918
• Lead Sponsor: Benha University

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.

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 Timeline

• Study Start: 2023-01-22
• Primary Completion: 2024-02-22
• Status Verified: 2024-04
• Study Completion: 2024-04-03
• Study First Submitted: 2024-05-01
• Study First Submitted QC: 2024-05-04
• Last Update Submitted: 2024-05-04
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector spinae plane group	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.
Serratus anterior plane group	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.

Primary Outcome Measures

Name	Time	Method
time of the first rescue analgesic dose	24 hours postoperatively	The time when the first dose of rescue analgesia was administered at the recovery room,

Secondary Outcome Measures

Name	Time	Method
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.	Heart rate (HR) was recorded immediately before induction of anaesthesia, 1
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.	Mean arterial pressure

Trial Locations

Locations (1)

Benha University; 🇪🇬 Banha, Egypt