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NCT Number: NCT04841564

Open Versus Ultrasound Approach for Serratus Anterior Block

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Other names: ultrasound approach

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.

Other names: open approach

Primary outcomes

  1. Morphine consumption given as a rescue analgesia

    Time frame: 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 outcomes

  1. The period for the first analgesic required

    Time frame: Up to 24 hours after the procedure

    duration of analgesia in minutes

  2. Mean arterial blood pressure

    Time frame: 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

  3. visual analogue score (VAS) at rest

    Time frame: 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.

  4. postoperative complications

    Time frame: 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.

  5. Heart rate

    Time frame: 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

  6. visual analogue score (VAS) at shoulder movement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

An Open Approach Versus Ultrasound Approach for Serratus Anterior Plane Block for Postoperative Analgesia After Modified Radical Mastectomy: A Non-inferiority Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2021
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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