Open Versus Ultrasound Approach for Serratus Anterior Block

NCT ID: NCT04841564

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-10
• Study Completion Date: 2024-07-20

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).

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ultrasound group

serratus anterior plane block will be done through ultrasound guidance

Group Type: ACTIVE_COMPARATOR

ultrasound approach of serratus anterior block

Intervention Type: 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.

Open group

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

Group Type: EXPERIMENTAL

open approach of serratus anterior block

Intervention Type: 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.

Interventions

ultrasound approach of serratus anterior block

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.

Intervention Type: PROCEDURE

open approach of serratus anterior block

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.

Intervention Type: PROCEDURE

Other Intervention Names

ultrasound approach; open approach

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Mohammed Alseoudy

Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmoud M Alseoudy, MD

Role: PRINCIPAL_INVESTIGATOR

mansoura university, faculty of medicine

Locations

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

R.21.03.1262

Identifier Type: -

Identifier Source: org_study_id