Başakşehir Çam & Sakura City Hospital
Istanbul, Basaksehir, 34480, Turkey (Türkiye)
NCT Number: NCT07502846
The serratus anterior plane block (SAPB) is an ultrasound-guided fascial plane block used for perioperative analgesia in thoracic and breast surgeries. This technique involves the injection of local anesthetic into either the superficial or deep interfascial plane around the serratus anterior muscle at the mid-axillary line, targeting the lateral cutaneous branches of the intercostal nerves and providing analgesia to the anterolateral thoracic wall. The present prospective, comparative, single-blind clinical study aims to compare the postoperative analgesic efficacy of superficial and deep SAPB techniques in patients undergoing mammoplasty surgery. The primary objective is to evaluate total opioid consumption within the first 24 hours postoperatively,while secondary outcomes include postoperative pain scores,additional analgesic requirements, postoperative nausea and vomiting, patient satisfaction, time to first mobilization, and vital signs within the first 24 hours postoperatively. The results of this study may help determine the more effective SAPB technique for improving postoperative pain control and reducing opioid use in patients undergoing mammoplasty.
This study is active but is not currently recruiting participants.
Notify Me18 year–75 year
Female
Interventional
Not applicable
Istanbul, Basaksehir, 34480, Turkey (Türkiye)
Mammoplasty surgery is frequently associated with moderate to severe postoperative pain. Inadequate postoperative pain control may negatively affect patient recovery, delay mobilization, and increase opioid consumption. Traditionally, opioids have been widely used for the management of postoperative pain; however, opioid-related adverse effects and the growing concerns regarding opioid misuse have encouraged the use of multimodal analgesia strategies. Regional anesthesia techniques have therefore become an essential component of postoperative pain management and Enhanced Recovery After Surgery (ERAS) protocols.
Peripheral nerve blocks provide effective analgesia, reduce opioid consumption, and improve patient comfort during the postoperative period. In recent years, ultrasound-guided fascial plane blocks have gained increasing popularity due to their relative simplicity, safety, and favorable balance between sensory and motor blockade.
The serratus anterior plane block (SAPB), first described by Rafael Blanco in 2013, is an ultrasound-guided regional anesthesia technique used for analgesia in thoracic and breast surgeries. In this technique, local anesthetic is injected either into the superficial plane between the latissimus dorsi and serratus anterior muscles or into the deep plane between the serratus anterior muscle and the ribs at the mid-axillary line. This block targets the lateral cutaneous branches of the intercostal nerves and provides analgesia to the anterolateral thoracic wall.
Although SAPB has been increasingly used in breast surgeries, there is limited evidence comparing the analgesic efficacy of superficial and deep SAPB techniques in mammoplasty procedures. Therefore, further studies are needed to determine which technique provides superior postoperative analgesia and reduces opioid consumption more effectively.
This prospective, comparative, single-blind clinical study aims to compare the postoperative analgesic effectiveness of superficial and deep serratus anterior plane block techniques in patients undergoing mammoplasty surgery. Adult female patients aged 18-75 years with ASA physical status I-III scheduled for elective mammoplasty surgery will be included in the study. After ultrasound-guided SAPB administration, postoperative opioid consumption within the first 24 hours,pain scores,additional analgesic requirements, vital parameters, ,postoperative nausea and vomiting, patient satisfaction scores, Quality of postoperative recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire,time to first mobilization, and the length of hospital stay will be recorded and analyzed.
The results of this study are expected to contribute to the optimization of postoperative pain management strategies in mammoplasty surgery by identifying the more effective SAPB technique for reducing postoperative pain and opioid consumption.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided superficial serratus anterior plane block performed at the mid-axillary line by injecting bupivacaine between the latissimus dorsi and serratus anterior muscles to provide postoperative analgesia in patients undergoing mammoplasty surgery.
Ultrasound-guided deep serratus anterior plane block performed at the mid-axillary line by injecting bupivacaine between the serratus anterior muscle and the ribs to provide postoperative analgesia in patients undergoing mammoplasty surgery.
Time frame: Within the first 24 hours postoperatively
Total opioid consumption required for postoperative analgesia in patients undergoing mammoplasty surgery.
Time frame: Within the first 24 hours postoperatively
Postoperative pain intensity assessed using the Numeric Rating Scale (0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Time frame: Within the first 24 hours postoperatively
Requirement for rescue analgesia during the postoperative period.
Time frame: Within the first 24 hours postoperatively
Occurrence of postoperative nausea and vomiting during the postoperative period.Nausea-vomiting descriptive scale (0: none, 1: mild nausea, 2: nausea, 3: vomiting once, 4: vomiting more than once) will be noted and 0.1 mg/kg IV ondansetron will be administered for scores of 2 and above.
Time frame: Within the first 24 hours postoperatively
Patient satisfaction with postoperative pain management assessed using a four-point scale (1 = not satisfied, 4 = very satisfied).
Quality of postoperative recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire. The QoR-15 is a validated patient-reported outcome measure evaluating postoperative recovery across multiple domains, with scores ranging from 0 to 150, where higher scores indicate better recovery.
Time frame: Within the first 24 hours postoperatively
Time from the end of surgery to the first postoperative mobilization.
Time frame: Within the first 24 hours postoperatively
Participants' blood pressure (mmHg) will be monitored for 24 hours: in the operating room before the serratus anterior plane block and after block application, and postoperatively at 0, 1, 6, 12, and 24 hours.
Time frame: Postoperative 24 hours
Participants' heart rate (bpm) will be monitored for 24 hours: in the operating room before the serratus anterior plane block and after block application, and postoperatively at 0, 1, 6, 12, and 24 hours.
Time frame: Postoperative 24 hours
Participants' oxygen saturation (SpO₂, %) will be monitored for 24 hours: in the operating room before the serratus anterior plane block and after block application, and postoperatively at 0, 1, 6, 12, and 24 hours.
Time frame: From surgery date until hospital discharge, assessed up to 7 days.
Duration of hospitalization from the time of surgery until hospital discharge, measured in days.
Başakşehir Çam & Sakura City Hospital
Other Gov
Comparison of the Postoperative Analgesic Efficacy of Superficial and Deep Serratus Anterior Plane Blocks in Patients Undergoing Mammoplasty Surgery
Acronym: DSAPvsSSAP
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