Open Versus Ultrasound Approach for Serratus Anterior Block

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04841564
• Other study ID #: R.21.03.1262
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2021
• Est. completion date: September 10, 2023

Study information

• Verified date: March 2023
• Source: Mansoura University
• Contact: Mahmoud M Alseoudy, MD
• Phone: +201006224551
• Email: drs3ody.mansora[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 10, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Department of Anesthesia, Mansoura University Hospitals	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The period for the first analgesic required	duration of analgesia in minutes	Up to 24 hours after the procedure
Secondary	Mean arterial blood pressure	Mean arterial blood pressure in mmHg will be recorded at baseline before surgical incision and postoperatively at 1, 4, 8, 12, 24 hours	Up to 24 hours after the procedure
Secondary	visual analogue score (VAS) at rest	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.	Up to 24 hours after the procedure
Secondary	postoperative complications	Any postoperative events like nausea, vomiting, respiratory depression( respiratory rate less than 12), urine retention, pruritis, local anesthetic toxicity and pneumothorax will be recorded.	Up to 24 hours after the procedure
Secondary	Heart rate	Heart rate in beats per minute will be recorded at baseline before surgical incision and postoperatively at 1, 4, 8, 12, 24 hours	Up to 24 hours after the procedure
Secondary	visual analogue score (VAS) at shoulder movement	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.	Up to 24 hours after the procedure