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

NCT06188156 | Unknown DMC

• 1 other identifier: Ahmed Elbasuni Ali
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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)

Conditions

Anesthesia; Radical Mastectomy

Keywords

thoracic epidural blockage; Ultrasound Guided Serratus Anterior Plane Block; Pectoral Nerve Block II; Radical Mastectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Thoracic Epidural Block(Group 1)

ACTIVE COMPARATOR

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.

Procedure: Anethesia

Ultrasound Guided Sserratus Anterior Plane Block (Group 2)

ACTIVE COMPARATOR

About 33 Patients will receive Ultrasound Guided Sserratus Anterior Plane Block( SAPB) with an injection of 30 ml bupivacaine 0.25% .

Procedure: Anethesia

Ultrasound Guided Pectoral Nerve Block (Group 3)

ACTIVE COMPARATOR

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.

Procedure: Anethesia

Interventions

Anethesia PROCEDURE

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.

Thoracic Epidural Block(Group 1); Ultrasound Guided Pectoral Nerve Block (Group 3); Ultrasound Guided Sserratus Anterior Plane Block (Group 2)

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 35-65 years.
• BMI 18.5 - 25 kg/m2.
• American Society of Anesthesiologists (ASA) I-II.

You may not qualify if:

• Patient refusal.
• Coagulopathy.
• Mental and psychiatric disorders.
• History of chronic pain.
• Hypersensitivity or contraindication to any of study drugs
• Previous chemotherapy.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University hospitals

Cairo, Egypt

RECRUITING

Study Officials

• Alaa Aldine Mahmoud Said, Professor

  Al-Azhar University, Faculty of medicine for boys

  STUDY CHAIR

Central Study Contacts

Ahmed Elbasuni, MSC

CONTACT

+201125373436; ahmedelbasuni86@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia, intensive care and pain management Faculty of Medicine

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: January 3, 2024
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 28, 2024
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)