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RecruitingNCT06188156Updated Jan 3, 2024

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

An interventional study of Anethesia in Anesthesia and Radical Mastectomy, sponsored by Azhar University. Recruiting at 1 site in Egypt. Open to female participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-01-03.

Sponsored by Azhar University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2024, 2 years 8 months ago, but the record still lists the study as recruiting.
  • Registered 10 months after the study started (first participant enrolled Feb 2023, registered Dec 2023).
  • Started Feb 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
Female
01

Study 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)

Read the 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

02

Conditions studied

  • Anesthesia
  • Radical Mastectomy

Keywords

  • thoracic epidural blockage
  • Ultrasound Guided Serratus Anterior Plane Block
  • Pectoral Nerve Block II
  • Radical Mastectomy
03

In context

Lead sponsor

Azhar University is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patient refusal.
  • Coagulopathy.
  • Mental and psychiatric disorders.
  • History of chronic pain.
  • Hypersensitivity or contraindication to any of study drugs
  • Previous chemotherapy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
99 participants (estimated)

Study arms

  • Active comparator
    Thoracic Epidural Block(Group 1)

    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

  • Active comparator
    Ultrasound Guided Sserratus Anterior Plane Block (Group 2)

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

    Procedure: Anethesia

  • Active comparator
    Ultrasound Guided Pectoral Nerve Block (Group 3)

    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

  • ProcedureAnethesia

    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.

06

What researchers measure

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

    Time frame: First 24-hour analgesic after Mastectomy

07

Study locations

1 of 1 sites recruiting
  • Al-Azhar University hospitals
    Cairo, Egypt
    • Mohamed Abdelgawad, Assist.Prof · Contact · abosoad.mohamed2017@gmail.com · +201091945931
    • Mohamed Abdelgawad Aboelsuod, Assist.Prof. · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06188156
Lead sponsor
Azhar University
Responsible party
mohamed A Aboelsuod, MD (Assistant Professor of Anesthesia, intensive care and pain management Faculty of Medicine, Azhar University) — Principal investigator
First posted
Jan 3, 2024
Start date
Feb 1, 2023
Primary completion
Feb 1, 2024 (estimated)
Completion
Feb 28, 2024 (estimated)
Last update
Jan 3, 2024

Study contacts

Ahmed Elbasuni, MSC
Contact
ahmedelbasuni86@yahoo.com
+201125373436
Alaa Aldine Mahmoud Said, Professor
study chair · Al-Azhar University, Faculty of medicine for boys

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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