Breast CancermastectomyNCT07737132
Comparison of Postoperative Analgesic Efficacy of Two Different Blocks in Modified Radical Mastectomy Surgery
A study testing Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Ultrasound-Guided Serratus Anterior Plane Block (SAPB) in people with Breast Cancer and Postoperative Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Postoperative Pain
- What is being tested?
- Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Ultrasound-Guided Serratus Anterior Plane Block (SAPB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 1 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 to 65 years.
- Scheduled for elective modified radical mastectomy under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Body mass index (BMI) <35 kg/m².
- Normal coagulation profile (including INR and platelet count).
- Normal liver and renal function tests.
- Able to understand the study procedures and provide written informed consent.
Who cannot join
- Known allergy or hypersensitivity to local anesthetics.
- Coagulation disorders or bleeding diathesis.
- Infection or inflammation at the planned block site.
- ASA physical status IV or higher.
- Chronic opioid use or chronic pain requiring long-term analgesic therapy.
- Advanced hepatic or renal insufficiency.
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- Severe pulmonary disease.
- Opioid use within 24 hours before surgery.
- Cognitive impairment or inability to complete postoperative assessments.
- Revision breast surgery.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan 2. Abdulhamid Han Training and Research Hospital
Istanbul, Uskudar, 34668
Dilek Metin Yamac, 05054959792, ddilekmetin@hotmail.com
About this study
Official title: Comparison of Postoperative Analgesic Efficacy of Superior Posterior Serratus Intercostal Plane Block (SPSIP) and Anterior Serratus Plane Block in Modified Radical Mastectomy Surgery
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Postoperative Pain
- Being tested
- Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Ultrasound-Guided Serratus Anterior Plane Block (SAPB)
- Keywords
- Modified Radical Mastectomy, Postoperative Pain, Ultrasound-Guided Nerve Block, Serratus Anterior Plane Block, Serratus Posterior Superior Intercostal Plane Block
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB)Procedure or surgery
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 Serratus Anterior Plane Block (SAPB)Procedure or surgery
Ultrasound-guided injection of 30 mL of 0.25% bupivacaine into the serratus anterior plane before induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| SPSIP Block | Experimental | 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. Receives: Procedure: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) |
| SAP Block | Active comparator | 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. Receives: Procedure: Ultrasound-Guided Serratus Anterior Plane Block (SAPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after surgery (assessed at PACU arrival, 30 minutes, 2, 4, and 24 hours postoperatively)
Secondary outcomes (6)
Intraoperative remifentanil consumption
Total intraoperative remifentanil consumption will be recorded in micrograms.
Measured: During surgery
Postoperative tramadol consumption
Total tramadol consumption delivered by patient-controlled analgesia (PCA) during the first 24 postoperative hours.
Measured: 24 hours after surgery
Postoperative nausea and vomiting
Postoperative nausea and vomiting will be evaluated using a 5-point PONV score.
Measured: 24 hours after surgery
Quality of recovery
Quality of recovery will be evaluated using the Quality of Recovery-40 (QoR-40) questionnaire.
Measured: 24 hours after surgery
Rescue analgesic requirement
The number of patients requiring rescue analgesia and the total rescue analgesic dose administered will be recorded.
Measured: 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.
Measured: From block performance until 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Aug 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided serratus anterior plane block (SAPB) or serratus posterior superior intercostal plane block (SPSIPB). Outcomes will be compared between the two parallel groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dilek M Yamac, Principal investigator, Sultan Abdülhamid Han education and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737132
- Sponsor's protocol ID
- SBU-ANESTEZİ-DMY-06
- Acronym
- mastectomy
- Status last verified
- Oct 2026
- First submitted
- 27 Jul 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tang W, Luo G, Lu Y, Chen C, Liu H, Li Y. Application of a new serratus anterior plane block in modified radical mastectomy under ultrasound guidance: A prospective, randomized controlled trial. J Clin Anesth. 2021 Nov;74:110377. doi: 10.1016/j.jclinane.2021.110377. Epub 2021 Jun 9.
PubMed 34118568Meng J, Zhao HY, Zhuo XJ, Shen QH. Postoperative Analgesic Effects of Serratus Anterior Plane Block for Thoracic and Breast Surgery: A Meta-analysis of Randomized Controlled Trials. Pain Physician. 2023 Mar;26(2):E51-E62.
PubMed 36988359Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block for breast surgery: a report of three cases, novel block and new indication. Minerva Anestesiol. 2023 Nov;89(11):1054-1056. doi: 10.23736/S0375-9393.23.17432-3. Epub 2023 Jun 1. No abstract available.
PubMed 37272274