Open Versus Ultrasound Approach for Serratus Anterior Block

Not Applicable

Completed

• Conditions: Analgesia
• Interventions: Procedure: open approach of serratus anterior block; Procedure: ultrasound approach of serratus anterior block

• Registration Number: NCT04841564
• Lead Sponsor: Mansoura University

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.

Detailed Description

Modified radical mastectomy (MRM) is one of the most common surgeries performed, and one that may be associated with significant acute postoperative pain in breast surgery. Acute postoperative pain is an independent risk factor in the development of chronic post-mastectomy pain.

Various regional anesthetic procedures have been tried to provide better acute pain control and, consequently, less chronic pain. They can reduce perioperative opiates requirement and thereby decreasing their possible side effects. These regional procedures include local wound infiltration, thoracic epidural, and thoracic paravertebral block (PVB). pectoral nerves block type-1 (PECSI), pectoral nerves block type-2 (PECS II), and serratus plane block.

Ultrasound-guided Serratus anterior plane (SAP) block is an interventional technique that recently gained popularity in the context of breast surgery. SAP block resulted in better hemodynamic stability, early ambulation, and reduced duration of hospitalization as well as hospital costs in postoperative breast patients.

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. Also, ultrasound use depends on equipment quality and investigator experience.

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 in providing analgesia to female patients undergoing modified radical mastectomy. The primary endpoint will be the total dose of morphine consumed in the 1st postoperative 24 h. secondary outcomes will be the time of the first analgesic request (duration of the pain-free periods after surgery in the1st postoperative 24 hours), postoperative visual analog score (VAS), postoperative modified Ramsay sedation score, and PONV (post-operative nausea and vomiting).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-08
• Study Start: 2021-04-10
• Study First Posted: 2021-04-12
• Primary Completion: 2024-06-15
• Study Completion: 2024-07-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open group	open approach of serratus anterior block	serratus anterior plane block will be done after mastectomy through the open wound
ultrasound group	ultrasound approach of serratus anterior block	serratus anterior plane block will be done through ultrasound guidance

Primary Outcome Measures

Name	Time	Method
Morphine consumption given as a rescue analgesia	Up to 24 hours after the procedure	The amount of morphinel consumption in milligrams given as a rescue analgesia to patients when the vas score is more than 3

Secondary Outcome Measures

Name	Time	Method
Mean arterial blood pressure	Up to 24 hours after the procedure	Mean arterial blood pressure in mmHg will be recorded at baseline before surgical incision and postoperatively at 1, 4, 8, 12, 24 hours
visual analogue score (VAS) at rest	Up to 24 hours after the procedure	pain intensity will be assessed at rest with the 10 point visual analogue score (VAS) where 0 =no pain and 10 = the worst imaginable pain and the time points of measurements will be at 0, 1, 4, 8, 12 and 24 hours post-operatively.
visual analogue score (VAS) at shoulder movement	Up to 24 hours after the procedure	pain intensity will be assessed at shoulder movement with the 10 point visual analogue score (VAS) where 0 =no pain and 10 = the worst imaginable pain and the time points of measurements will be at 0, 1, 4, 8, 12 and 24 hours post-operatively.
The period for the first analgesic required	Up to 24 hours after the procedure	duration of analgesia in minutes
postoperative complications	Up to 24 hours after the procedure	Any postoperative events like nausea, vomiting, respiratory depression( respiratory rate less than 12), urine retention, pruritis, local anesthetic toxicity and pneumothorax will be recorded.
Heart rate	Up to 24 hours after the procedure	Heart rate in beats per minute will be recorded at baseline before surgical incision and postoperatively at 1, 4, 8, 12, 24 hours

Trial Locations

Locations (1)

Department of Anesthesia, Mansoura University Hospitals; 🇪🇬 Mansoura, Dakahlia, Egypt