An interventional study of Ultrasound-Guided Serratus Anterior Plane Block and Bupivacaine in Quality of Recovery After Mastectomy, Serratus Anterior Plane Block and Postoperative Pain, sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Not applicable, Interventional, and Treatment
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 80 is close to the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Bakirkoy Dr. Sadi Konuk Research and Training Hospital is the lead sponsor of 122 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will receive ultrasound-guided serratus anterior plane block after induction of general anesthesia and before surgical incision. The block will be performed on the operative side using 25 mL of 0.25% bupivacaine, in addition to standardized general anesthesia and postoperative analgesic management.
Procedure: Ultrasound-Guided Serratus Anterior Plane Block · Drug: Bupivacaine
Participants assigned to this arm will receive ultrasound-guided serratus anterior plane block after completion of surgery and before extubation. The block will be performed on the operative side using 25 mL of 0.25% bupivacaine, in addition to standardized general anesthesia and postoperative analgesic management.
Procedure: Ultrasound-Guided Serratus Anterior Plane Block · Drug: Bupivacaine
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.
Also known as: 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.
Postoperative Quality of Recovery at 24 Hours
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: 24 hours after surgery
Resting Postoperative Pain Scores
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: Postoperative 0 to 24 hours
Intraoperative Remifentanil Consumption
Total intraoperative remifentanil consumption will be recorded and compared between groups.
Time frame: During surgery
Postoperative Opioid Consumption
Total opioid consumption during the first 24 postoperative hours will be calculated based on tramadol use.
Time frame: Postoperative 0 to 24 hours
Postoperative Non-Opioid Analgesic Consumption
Total non-opioid analgesic consumption during the first 24 postoperative hours will be recorded, including paracetamol use.
Time frame: Postoperative 0 to 24 hours
Time to First Analgesic Requirement
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
Postoperative Nausea and Vomiting
The occurrence of postoperative nausea and vomiting will be assessed during the first 24 postoperative hours.
Time frame: Postoperative 0 to 24 hours
Length of Hospital Stay
Length of hospital stay will be recorded as the number of days from surgery to discharge.
Time frame: From surgery until hospital discharge, assessed up to 30 days.
C-Reactive Protein Level
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
White Blood Cell Count
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
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
Absolute lymphocyte count will be measured from the complete blood count and reported in ×10\^9/L.
Time frame: Postoperative 6 hours
Neutrophil-to-Lymphocyte Ratio
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: Postoperative 6 hours
Intraoperative Heart Rate
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
Intraoperative Mean Arterial Pressure
Mean arterial pressure will be recorded in mmHg during the intraoperative period and compared between groups.
Time frame: From induction of general anesthesia to completion of surgery
Plan to share: Undecided
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine
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