An interventional study of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Ultrasound-Guided Serratus Anterior Plane Block (SAPB) in Breast Cancer and Postoperative Pain, sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Not applicable, Interventional, and Treatment
Postoperative pain following modified radical mastectomy remains a significant clinical challenge and may delay recovery, impair patient comfort, and increase opioid consumption. Ultrasound-guided fascial plane blocks have become an important component of multimodal analgesia for breast surgery. The serratus anterior plane block (SAPB) is an established regional anesthesia technique that provides effective postoperative analgesia. The serratus posterior superior intercostal plane block (SPSIPB) is a recently described interfascial block with promising analgesic effects, but evidence comparing its efficacy with SAPB in breast surgery remains limited.
This prospective, randomized, double-blind, single-center clinical trial aims to compare the postoperative analgesic efficacy of ultrasound-guided SPSIPB and SAPB in patients undergoing modified radical mastectomy under general anesthesia. Seventy female patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III will be randomly assigned to receive either SPSIPB or SAPB before surgery. The primary outcome is postoperative pain intensity assessed using the Visual Analog Scale (VAS). Secondary outcomes include intraoperative remifentanil consumption, cumulative tramadol consumption during the first 24 postoperative hours, postoperative nausea and vomiting (PONV), quality of recovery assessed with the QoR-40 questionnaire, rescue analgesic requirements, and block-related complications. The findings of this study are expected to provide evidence regarding the comparative effectiveness and safety of these two interfascial plane blocks for postoperative analgesia in breast cancer surgery.
Breast cancer surgery, particularly modified radical mastectomy, is frequently associated with moderate to severe postoperative pain. Inadequate pain control may impair respiratory function, delay mobilization, prolong hospital stay, increase opioid consumption, and contribute to the development of persistent postsurgical pain. Therefore, effective multimodal analgesia incorporating regional anesthesia techniques has become an important component of perioperative care in breast surgery.
Among ultrasound-guided fascial plane blocks, the serratus anterior plane block (SAPB) has been widely adopted because of its ability to block the lateral cutaneous branches of the intercostal nerves, resulting in reduced postoperative pain scores and opioid requirements. More recently, the serratus posterior superior intercostal plane block (SPSIPB) has been introduced as a novel interfascial block that may provide broader thoracic dermatomal spread through injection between the serratus posterior superior and intercostal muscles. Although early clinical reports have demonstrated promising analgesic efficacy, comparative evidence between SPSIPB and SAPB in breast surgery remains limited.
This study is designed as a prospective, randomized, double-blind, single-center clinical trial to compare the analgesic efficacy of ultrasound-guided SPSIPB and SAPB in patients undergoing modified radical mastectomy under general anesthesia. Seventy female patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) physical status I-III who meet the eligibility criteria will be enrolled after providing written informed consent. Participants will be randomized in a 1:1 ratio using sealed-envelope allocation to receive either ultrasound-guided SPSIPB or SAPB before induction of general anesthesia. Both blocks will be performed using 30 mL of 0.25% bupivacaine under standardized ultrasound guidance by experienced anesthesiologists.
General anesthesia and postoperative analgesic management will be standardized for all participants. Intraoperative anesthetic management will include propofol, fentanyl, rocuronium, sevoflurane, and remifentanil according to institutional practice. Following surgery, all patients will receive standardized multimodal analgesia consisting of intravenous paracetamol, tramadol patient-controlled analgesia (PCA), and rescue analgesics when clinically indicated.
The primary outcome is postoperative pain intensity assessed using the Visual Analog Scale (VAS) at predefined postoperative time points. Secondary outcomes include intraoperative remifentanil consumption, cumulative tramadol consumption during the first 24 postoperative hours, postoperative nausea and vomiting (PONV) scores, rescue analgesic requirements, quality of recovery measured using the QoR-40 questionnaire at 24 hours, block-related complications, and other postoperative adverse events.
The findings of this study are expected to clarify whether SPSIPB provides analgesia comparable or superior to SAPB for patients undergoing breast cancer surgery. The results may contribute to optimizing regional anesthesia strategies and improving postoperative recovery while reducing perioperative opioid consumption.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 70 is close to the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey is the lead sponsor of 108 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) using 30 mL of 0.25% bupivacaine before induction of general anesthesia. General anesthesia and postoperative analgesic management will be standardized for all participants.
Procedure: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB)
Participants will receive an ultrasound-guided Serratus Anterior Plane Block (SAPB) using 30 mL of 0.25% bupivacaine before induction of general anesthesia. General anesthesia and postoperative analgesic management will be standardized for all participants.
Procedure: Ultrasound-Guided Serratus Anterior Plane Block (SAPB)
An ultrasound-guided serratus posterior superior intercostal plane block will be performed before induction of general anesthesia using 30 mL of 0.25% bupivacaine injected into the fascial plane between the serratus posterior superior muscle and the intercostal muscles.
Ultrasound-guided injection of 30 mL of 0.25% bupivacaine into the serratus anterior plane before induction of general anesthesia.
Postoperative pain intensity
Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded at predefined postoperative time points.
Time frame: 24 hours after surgery (assessed at PACU arrival, 30 minutes, 2, 4, and 24 hours postoperatively)
Intraoperative remifentanil consumption
Total intraoperative remifentanil consumption will be recorded in micrograms.
Time frame: During surgery
Postoperative tramadol consumption
Total tramadol consumption delivered by patient-controlled analgesia (PCA) during the first 24 postoperative hours.
Time frame: 24 hours after surgery
Postoperative nausea and vomiting
Postoperative nausea and vomiting will be evaluated using a 5-point PONV score.
Time frame: 24 hours after surgery
Quality of recovery
Quality of recovery will be evaluated using the Quality of Recovery-40 (QoR-40) questionnaire.
Time frame: 24 hours after surgery
Rescue analgesic requirement
The number of patients requiring rescue analgesia and the total rescue analgesic dose administered will be recorded.
Time frame: 24 hours after surgery
Block-related complications
Complications associated with the regional block, including local anesthetic systemic toxicity, vascular puncture, pneumothorax, hematoma, infection, or block failure, will be recorded.
Time frame: From block performance until 24 hours after surgery
Plan to share: No
Started Aug 2026 (actual). Primary completion is estimated for Feb 2027, 6 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 6 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey →