Analgesic Efficacy of Ultrasound Guided Serratus Anterior Plane Block and Pectoral Nerve Block II

Anesthesia Clinical Trial

Official title:

Analgesic Efficacy of Ultrasound Guided Serratus Anterior Plane Block and Pectoral Nerve Block II Compared to Thoracic Epidural Block After Unilateral Modified Radical Mastectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06188156
• Other study ID #: Ahmed Elbasuni Ali
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: December 2023
• Source: Azhar University
• Contact: Ahmed Elbasuni, MSC
• Phone: +201125373436
• Email: ahmedelbasuni86[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Modified Radical Mastectomy accounts for 31% of all breast surgeries and considered the fundamental surgical management for breast cancer. Nearly 40-60% of patients experience severe acute postoperative pain. This pain might persist for 6-12 months and result in post-mastectomy pain syndrome and complex regional pain syndrome (causalgia)

Description:

There are some local or regional nerve blocks in breast surgeries performed as core components of multimodal analgesia and enhanced recovery after surgery (ERAS), including thoracic epidural (TEB), interscalene brachial plexus, paravertebral, ultrasound-guided pectoral nerve block ( PECS II ), ultrasound-guided serratus anterior plane block (SAPB) and erector spinae plane block .

Thoracic epidural (TEB) is the gold standard technique following breast surgery, but there is still a problem with the adequacy of thoracic and axillary blockage during lymph node dissection .

Modified PECS's block" or PECS block type II aimed to block the axilla that is vital for axillary clearances and the intercostal nerves, necessary for wide excisions which can provide analgesia after breast surgery.

In the ultrasound-guided serratus anterior plane block (SAPB), the local anesthetic (LA) is injected in the compartment between the serratus anterior and latissimus dorsi muscles. SAPB anesthetizes the intercostobrachial nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve, and thoracodorsal nerve thus providing analgesia for breast and lateral thoracic wall surgeries

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: February 28, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

• Women aged 35-65 years.

• BMI 18.5 - 25 kg/m2.

• American Society of Anesthesiologists (ASA) I-II.

Exclusion Criteria:

• Patient refusal.

• Coagulopathy.

• Mental and psychiatric disorders.

• History of chronic pain.

• Hypersensitivity or contraindication to any of study drugs

• Previous chemotherapy.

Related Conditions & MeSH terms

• Anesthesia
• Radical Mastectomy

Intervention

Procedure:
• Anethesia
To assess the effectiveness of thoracic epidural blockage versus ultrasonic guided PECS II block versus ultrasound guided serratus anterior plane block for postoperative pain management in modified radical mastectomy.

Locations

Country	Name	City	State
Egypt	Al-Azhar University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Post-operative Pain	Assessment of the pain post-operatively in patients with pain assessed by VAS score : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain	First 24-hour analgesic after Mastectomy