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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).

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Sites and contacts
Official record

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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)
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
  • Sultan 2. Abdulhamid Han Training and Research Hospital

    Istanbul, Uskudar, 34668

    Dilek Metin Yamac, 05054959792, ddilekmetin@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07737132
Study groupRoleWhat they receive
SPSIP BlockExperimentalParticipants 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 BlockActive comparatorParticipants 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.

  1. 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)
  1. Intraoperative remifentanil consumption

    Total intraoperative remifentanil consumption will be recorded in micrograms.

    Measured: During surgery

  2. Postoperative tramadol consumption

    Total tramadol consumption delivered by patient-controlled analgesia (PCA) during the first 24 postoperative hours.

    Measured: 24 hours after surgery

  3. Postoperative nausea and vomiting

    Postoperative nausea and vomiting will be evaluated using a 5-point PONV score.

    Measured: 24 hours after surgery

  4. Quality of recovery

    Quality of recovery will be evaluated using the Quality of Recovery-40 (QoR-40) questionnaire.

    Measured: 24 hours after surgery

  5. 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

  6. 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.

  1. First posted30 Jul 2026
  2. Study start1 Aug 2026
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

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)
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 34118568
  • Meng 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 36988359
  • Ciftci 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

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