Clinical trial NCT04841564: Open Versus Ultrasound Approach for Serratus Anterior Block
Official title: An Open Approach Versus Ultrasound Approach for Serratus Anterior Plane Block for Postoperative Analgesia After Modified Radical Mastectomy: A Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: serratus anterior block
ultrasound
open
mastectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Morphine consumption given as a rescue analgesia
timeFrame: Up to 24 hours after the procedure
Secondary outcomes:
measure: The period for the first analgesic required
timeFrame: Up to 24 hours after the procedure
measure: Mean arterial blood pressure
timeFrame: Up to 24 hours after the procedure
measure: visual analogue score (VAS) at rest
timeFrame: Up to 24 hours after the procedure
measure: postoperative complications
timeFrame: Up to 24 hours after the procedure
measure: Heart rate
timeFrame: Up to 24 hours after the procedure
measure: visual analogue score (VAS) at shoulder movement
timeFrame: Up to 24 hours after the procedure
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Department of Anesthesia, Mansoura University Hospitals
state: Dakahlia
Study officials:
affiliation: mansoura university, faculty of medicine
name: Mahmoud M Alseoudy, MD
role: PRINCIPAL_INVESTIGATOR
References: