Open Versus Ultrasound Approach for Serratus Anterior Block

NCT04841564 | Completed

• 1 other identifier: R.21.03.1262
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Ultrasound-guided Serratus anterior plane (SAP) block is an interventional technique that recently gained popularity in the context of postoperative analgesia after breast surgery. Some limitations may be encountered during the use of ultrasound, such as obesity, tumor invasion of the surrounding muscles, which may lead to poor ultrasound image quality. The investigators hypothesized that an open approach to serratus anterior block by infiltration of local anesthetic between serratus anterior muscle and ribs after tumor excision during surgery would be non-inferior to ultrasound-guided approach where the primary endpoint of this prospective randomized blind controlled study will be the total dose of morphine consumed in the 1st postoperative 24 h. The patients will be randomly allocated to an open approach group and ultrasound approach group to serratus anterior block using computer-generated random numbers and sealed opaque envelops. For any statistical tests used results will be considered as statistically significant if P-value ≤0.05.

Conditions

Analgesia

Keywords

serratus anterior block; ultrasound; open; mastectomy

Outcome Measures

Primary Outcomes (1)

• Morphine consumption given as a rescue analgesia

  The amount of morphinel consumption in milligrams given as a rescue analgesia to patients when the vas score is more than 3

  Up to 24 hours after the procedure

Secondary Outcomes (6)

• The period for the first analgesic required

  Up to 24 hours after the procedure

• Mean arterial blood pressure

  Up to 24 hours after the procedure

• visual analogue score (VAS) at rest

  Up to 24 hours after the procedure

• postoperative complications

  Up to 24 hours after the procedure

• Heart rate

  Up to 24 hours after the procedure

Study Arms (2)

ultrasound group

ACTIVE COMPARATOR

serratus anterior plane block will be done through ultrasound guidance

Procedure: ultrasound approach of serratus anterior block

Open group

EXPERIMENTAL

serratus anterior plane block will be done after mastectomy through the open wound

Procedure: open approach of serratus anterior block

Interventions

ultrasound approach of serratus anterior block PROCEDURE

After induction of general anesthesia, the ultrasound probe will be placed longitudinally oblique just below the mid-clavicle. After identifying the second rib, the probe will be moved caudally and laterally (obliquely), towards the mid-axillary line to identify the 3rd, 4th and 5th ribs.. The fascial plane between the serratus anterior muscle and latissimus dorsi muscle will be identified over the 4th rib in the mid-axillary region. The block will be performed with a needle (22-G, 50-mm) introduced in-plane to enter deep to the serratus anterior muscle, and 30 ml 0.25 bupivacaine will be injected.

Also known as: ultrasound approach

ultrasound group

open approach of serratus anterior block PROCEDURE

After resection of the breast and identification of the serratus anterior muscle, the surgeon will be asked to palpate the ribs below the clavicle and localize the fourth rib. A 22-G, 50-mm needle will be introduced deep to the serratus anterior muscle contacting the rib, and 30 ml 0.25 bupivacaine will be injected.

Also known as: open approach

Open group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status scores of I and II
• Elective unilateral breast surgery (modified radical mastectomy)

You may not qualify if:

• Patient refusal to participate in the study.
• Allergy to any medications used in the study.
• Patients with coagulopathy
• patients with psychiatric disorders.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (1)

• Mohammed ALseoudy M, Abd El-Ghaffar Saleh M, Saleh Elbalka S, Elmetwally Farahat T, Abdellatif Elebedy D, Elsayed Ahmed S. An open approach versus ultrasound approach for deep serratus anterior plane block for postoperative analgesia after modified radical mastectomy: A randomized controlled trial. Rev Esp Anestesiol Reanim (Engl Ed). 2025 Nov;72(9):501902. doi: 10.1016/j.redare.2025.501902. Epub 2025 Sep 4.

  PMID: 40914287 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mahmoud M Alseoudy, MD

  mansoura university, faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 12, 2021
• Study Start: April 10, 2021
• Primary Completion: June 15, 2024
• Study Completion: July 20, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)