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

Modified Radical Mastectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06404918
• Other study ID #: RC 23-11-2023
• Status: Completed
• Phase: N/A
• Start date: January 22, 2023
• Est. completion date: April 3, 2024

Study information

• Verified date: April 2024
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 3, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Modified Radical Mastectomy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Benha University	Banha

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.