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Not yet recruiting NCT07394868

Comparison of the Combined Serratus Anterior Plane Block Versus Superficial Serratus Anterior Plane Block

Observational Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Combined serratus plan block, Superficial serratus plane block.
Who it may be relevant to
Registry conditions: Pain. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of the Analgesic Efficacy of Combined Superficial and Deep Serratus Anterior Plane Block Versus Superficial Serratus Anterior Plane Block Following Modified Radical Mastectomy Surgery

Overview

Breast cancer is the most common malignancy in women; surgery is a cornerstone of breast cancer treatment, and modified radical mastectomy is one of the standard treatments. Postoperative pain can significantly reduce the quality of life in patients, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abiration during modified radical mastectomy, but their application is limited due to the complex nature of the procedures and serious complications. In recent years, there has been increasing interest in the newer, less invasive superficial serratus block and combined serratus block. Serratus anterior plane block (SAPB) can be applied in two ways. Deep SPB (DSPB) is applied under the serratus anterior muscle, while superficial SPB (YSPB) is applied above the serratus anterior muscle. In recent years, deep + superficial SPB, or combined SPB (KSPB), has begun to be applied in order to increase the area of effect of local anesthetics and to prevent block failure. This study aims to compare superficial and combined serratus anterior plane blocks.

Detailed description

Breast cancer is the most common malignancy in women; surgery is a cornerstone of breast cancer treatment, and modified radical mastectomy is one of the standard treatments. Postoperative pain can significantly reduce the quality of life in patients, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abiration during modified radical mastectomy, but their application is limited due to the complex nature of the procedures and serious complications. In recent years, there has been increasing interest in the newer, less invasive superficial serratus block and combined serratus block. Serratus anterior plane block (SAPB) can be applied in two ways. Deep SPB (DSPB) is applied under the serratus anterior muscle, while superficial SPB (YSPB) is applied above the serratus anterior muscle. In recent years, deep + superficial SPB, or combined SPB (KSPB), has begun to be applied in order to increase the area of effect of local anesthetics and to prevent block failure. This study aims to compare superficial and combined serratus anterior plane blocks. Superficial serratus anterior plane block procedure: The USG probe is placed on the 4th rib in the mid-axillary line. After visualizing the muscle structures up to the rib (latissimus dorsi, teres major, and serratus anterior), the needle is advanced using the in-plane technique to the serratus anterior muscle, under the latissimus dorsi muscle, and hydrodissection is performed with 2 ml of saline to ensure positional accuracy. Then, 15 ml of 0.25% bupivacaine is injected into this area. KSAB procedure: The USG probe is placed on the 4th rib in the mid-axillary line. After visualizing the muscle structures up to the rib (latissimus dorsi, teres major, and serratus anterior), the needle is advanced using the in-plane technique to the 4th rib, under the serratus anterior muscle, and onto the rib. Hydrodissection is performed with 2 ml of saline to ensure positional accuracy. Then, 15 ml of 0.25% bupivacaine is injected into this area. The needle is then withdrawn 1-2 cm and positioned over the serratus anterior muscle, below the latissimus dorsi muscle. Hydrodissection with 2 ml of saline is performed to ensure accuracy. Then, 15 ml of 0.25% bupivacaine is injected into this area. A total of 30 ml of bupivacaine will be injected, and the procedure will be terminated. In our clinic, multimodal analgesia is preferred for patients undergoing mastectomy. Peripheral nerve blocks (for all suitable and consenting patients) are used in conjunction with intravenous analgesic agents. Both block types are routinely applied in suitable patients who have undergone mastectomy.

Interventions

  • Other Combined serratus plan block
    Combined serratus plan block
  • Other Superficial serratus plane block
    Superficial serratus plane block

Primary outcome measures

  • Opioid consumption [Time frame: 24 hours postoperative]
Secondary outcome measures (6)
  • Numeric Rating Scale (NRS) [Time frame: 1 hour]
  • Numeric Rating Scale (NRS) [Time frame: 2 hour]
  • Numeric Rating Scale (NRS) [Time frame: 4 hour]
  • Numeric Rating Scale (NRS) [Time frame: 12 hour]
  • Numeric Rating Scale (NRS) [Time frame: 24 hour]
  • Patient satisfaction score [Time frame: 24 hour]

Eligibility criteria

Inclusion criteria

  • Individuals aged 18-80 years
  • Individuals with ASA scores I-II-III
  • Individuals with a Body Mass Index (BMI) between 18-40

Exclusion criteria

  • Individuals under 18 years of age and over 80 years of age
  • Individuals with an ASA score of IV or higher
  • Individuals with advanced comorbidities
  • Individuals with a history of bleeding diathesis
  • Patients with infection in the area to be blocked
  • Individuals with a BMI below 18 and above 40

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Etlik City Hospital — Ankara

Publications

  • Chai B, Wang Q, Du J, Chen T, Qian Y, Zhu Z, Feng Z, Kang X. Research Progress on Serratus Anterior Plane Block in Breast Surgery: A Narrative Review. Pain Ther. 2023 Apr;12(2):323-337. doi: 10.1007/s40122-022-00456-z. Epub 2022 Dec 9. PMID 36484891
  • Ozguner Y, Yazar CO, Aydin F, Zengin M, Arik E, Kotanoglu MS, Altinsoy S, Ergil J. Comparison of the analgesic efficacy of combined superficial and deep serratus anterior plane block versus pectoserratus plane block following modified radical mastectomy surgery. BMC Anesthesiol. 2025 Jul 28;25(1):358. doi: 10.1186/s12871-025-03213-9. PMID 40721998
  • Ulger G, Zengin M, Kucuk O, Baldemir R, Kaybal O, Tunc M, Sazak H, Alagoz A. Comparison of combined deep and superficial serratus anterior block with thoracic paravertebral block for postoperative pain in patients undergoing video-assisted thoracoscopic surgery. Turk J Med Sci. 2024 Aug 4;54(5):1021-1032. doi: 10.55730/1300-0144.5881. eCollection 2024. PMID 39473759

Identifiers

NCT: NCT07394868 · Etlik Kübra Tez

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗