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

Not Applicable

Recruiting

• Conditions: Anesthesia; Radical Mastectomy
• Interventions: Procedure: Anethesia

• Registration Number: NCT06188156
• Lead Sponsor: Azhar University

Brief 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)

Detailed 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

Study Timeline

• Study Start: 2023-02-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-10
• Study First Submitted QC: 2023-12-30
• Last Update Submitted: 2023-12-30
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 99

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracic Epidural Block(Group 1)	Anethesia	About 33 Patients will receive thoracic epidural block with an injection of a single shot of 15ml of 0.25% bupivacaine between T4 and T5 vertebrae.
Ultrasound Guided Sserratus Anterior Plane Block (Group 2)	Anethesia	About 33 Patients will receive Ultrasound Guided Sserratus Anterior Plane Block( SAPB) with an injection of 30 ml bupivacaine 0.25% .
Ultrasound Guided Pectoral Nerve Block (Group 3)	Anethesia	About 33 Patients will receive Ultrasound Guided Pectoral Nerve Block ( PECS II) with an injection of 20 ml bupivacaine 0.25% of pectoral-minor above the Serratus anterior muscle.

Primary Outcome Measures

Name	Time	Method
Measurement of Post-operative Pain	First 24-hour analgesic after Mastectomy	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

Trial Locations

Locations (1)

Al-Azhar University hospitals; 🇪🇬 Cairo, Egypt