Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Analgesia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 60 years
Gender
Only males

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 ane...

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).

Tracking Information

NCT #
NCT04841564
Collaborators
Not Provided
Investigators
Principal Investigator: Mahmoud M Alseoudy, MD mansoura university, faculty of medicine