Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, 34147, Turkey (Türkiye)
Location contact
Fatma Çiğdem ÖZAKIN, MD
CONTACT
Fatma Çiğdem ÖZAKIN, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07661212
Postoperative pain following mastectomy may adversely affect early mobilization, patient comfort, and overall quality of recovery. Serratus anterior plane block is an ultrasound-guided regional anesthesia technique that provides analgesia to the anterolateral thoracic wall and is increasingly used as part of multimodal analgesia for breast surgery. Although the analgesic efficacy of serratus anterior plane block has been investigated in breast surgery, the clinical impact of the timing of block administration remains insufficiently defined.
This prospective, randomized, controlled, patient and assessor blinded clinical trial will compare two different timings of ultrasound-guided serratus anterior plane block in adult female patients undergoing elective unilateral mastectomy under general anesthesia. Participants will be randomized to receive serratus anterior plane block either after induction of general anesthesia and before surgical incision, or after completion of surgery and before extubation. In both groups, the block will be performed under ultrasound guidance using 25 mL of 0.25% bupivacaine.
The primary outcome is postoperative quality of recovery at 24 hours, assessed using the Quality of Recovery-15 questionnaire. Secondary outcomes include postoperative pain scores at predefined time points during the first 24 postoperative hours, intraoperative remifentanil consumption, postoperative opioid and non-opioid analgesic requirements, time to first analgesic requirement, postoperative nausea and vomiting, length of hospital stay, complications, inflammatory response markers including CRP and neutrophil-to-lymphocyte ratio, and intraoperative hemodynamic variables.
The study is planned to enroll 80 participants at a single tertiary training and research hospital. The findings are expected to clarify whether preincisional administration of serratus anterior plane block provides superior postoperative recovery, analgesic efficacy, and modulation of inflammatory response compared with administration at the end of surgery.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
Istanbul, 34147, Turkey (Türkiye)
Fatma Çiğdem ÖZAKIN, MD
CONTACT
Fatma Çiğdem ÖZAKIN, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided serratus anterior plane block will be performed under general anesthesia on the operative side. With the patient in the supine position and the ipsilateral arm abducted, a high-frequency linear ultrasound probe will be placed at the midaxillary line around the fourth to fifth intercostal level. After identification of the latissimus dorsi and serratus anterior muscles, the block needle will be advanced using an in-plane technique, and 25 mL of 0.25% bupivacaine will be injected into the fascial plane between these muscles after negative aspiration. In the preincisional arm, the block will be performed after induction of general anesthesia and before surgical incision. In the end-of-surgery arm, the same block will be performed after completion of surgery and before extubation.
Other names: SAP Block
Bupivacaine 0.25%, 25 mL (62.5 mg), will be administered as a single ultrasound-guided injection into the serratus anterior plane on the operative side. In the preincisional arm, administration will occur after induction of general anesthesia and before surgical incision. In the end-of-surgery arm, administration will occur after completion of surgery and before extubation.
Time frame: 24 hours after surgery
Postoperative quality of recovery will be assessed using the Quality of Recovery-15 questionnaire. The postoperative 24-hour QoR-15 score will be compared between the preincisional serratus anterior plane block group and the end-of-surgery serratus anterior plane block group. Higher scores indicate better quality of recovery.
Time frame: Postoperative 0 to 24 hours
Resting pain intensity will be assessed using the Numeric Rating Scale at postoperative 0, 1, 4, 8, 12, 16, 20, and 24 hours.
Time frame: During surgery
Total intraoperative remifentanil consumption will be recorded and compared between groups.
Time frame: Postoperative 0 to 24 hours
Total opioid consumption during the first 24 postoperative hours will be calculated based on tramadol use.
Time frame: Postoperative 0 to 24 hours
Total non-opioid analgesic consumption during the first 24 postoperative hours will be recorded, including paracetamol use.
Time frame: Postoperative 0 to 24 hours
The time from admission to the postoperative recovery unit to the first requirement for rescue analgesia will be recorded.
Time frame: Postoperative 0 to 24 hours
The occurrence of postoperative nausea and vomiting will be assessed during the first 24 postoperative hours.
Time frame: From surgery until hospital discharge, assessed up to 30 days.
Length of hospital stay will be recorded as the number of days from surgery to discharge.
Time frame: Postoperative 6 hours
Serum C-reactive protein concentration will be measured as a marker of postoperative inflammatory response and reported in mg/L.
Time frame: Postoperative 6 hours
Absolute neutrophil count will be measured from the complete blood count and reported in ×10^9/L.
Time frame: Postoperative 6 hours
Absolute neutrophil count will be measured from the complete blood count and reported in ×10^9/L.
Time frame: Postoperative 6 hours
Absolute lymphocyte count will be measured from the complete blood count and reported in ×10^9/L.
Time frame: Postoperative 6 hours
The neutrophil-to-lymphocyte ratio will be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count. The ratio is unitless.
Time frame: From induction of general anesthesia to completion of surgery
Heart rate will be recorded in beats per minute during the intraoperative period and compared between groups.
Time frame: From induction of general anesthesia to completion of surgery
Mean arterial pressure will be recorded in mmHg during the intraoperative period and compared between groups.
Contact information is provided by the study sponsor or research team.
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Other Gov
The Effect of Serratus Anterior Plane Block Timing on Postoperative Quality of Recovery, Postoperative Pain, and Inflammatory Response in Elective Unilateral Mastectomy Surgery: A Prospective Randomized Controlled Clinical Trial
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