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Postoperative PainNCT07510269

Investigation of the Effects of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block on Perioperative Analgesia Management in Patients Scheduled for Mastectomy

A study testing SAP Block and SPSIP Block in people with Postoperative Pain and Nerve Block, run by Uludag University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate and compare the analgesic efficacy of two ultrasound-guided regional anesthesia techniques, the serratus anterior plane (SAP) block and the serratus posterior superior intercostal plane (SPSIP) block, in patients undergoing elective mastectomy surgery. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Postoperative Pain, Nerve Block, Mastectomy
What is being tested?
SAP Block and SPSIP Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Oct 2025to 15 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients aged between 18 and 75 years
  • Patients scheduled for elective mastectomy surgery
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Patients who provide written informed consent

Who cannot join

  • Patients who refuse to participate in the study
  • Patients with American Society of Anesthesiologists (ASA) physical status IV or V
  • Patients receiving anticoagulant therapy or with suspected coagulopathy
  • Patients with known allergy to local anesthetic agents
  • Infection at the site of block application
  • Pregnant patients or those with suspected pregnancy
Show all 10Show fewer
  • Patients with severe neurological or psychiatric disorders
  • Patients with severe cardiovascular disease
  • Patients with chronic opioid use
  • Patients with hepatic failure or renal failure (glomerular filtration rate <15 mL/min/1.73 m²)

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
  • Bursa Uludag University Hospital

    Bursa, Nilüfer, 16235

    Muhammed A MOL, MD, +90 506 253 62 54 ext. +902242954476, malihanmol@uludag.edu.tr

    Ali H Colak, MD, +90 506 560 35 17 ext. +902242953131, alihaydarcolak@uludag.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Mastektomi Planlanan Hastalarda Serratus Posterior Superior İnterkostal Plan Bloğu Ile Serratus Anterior Plan Bloğunun Peroperatif Analjezi Yönetimi Üzerine Etkilerinin Araştırılması

This study aims to evaluate and compare the analgesic efficacy of two ultrasound-guided regional anesthesia techniques, the serratus anterior plane (SAP) block and the serratus posterior superior intercostal plane (SPSIP) block, in patients undergoing elective mastectomy surgery. Postoperative pain following mastectomy is a common and significant clinical problem that negatively affects patient comfort, delays mobilization, and may prolong hospital stay. Although systemic analgesics are commonly used, they are associated with adverse effects such as sedation, constipation, and potential dependency.

In this randomized clinical study, female patients aged 18-75 years with ASA physical status I-III scheduled for elective mastectomy will be included after obtaining informed consent. Patients will be allocated into two groups to receive either SAP block or SPSIP block under ultrasound guidance prior to surgery. Standardized general anesthesia and perioperative analgesia protocols will be applied to all patients.

The primary objective is to compare postoperative pain scores between the two groups using the Numeric Rating Scale (NRS). Secondary outcomes include time to first analgesic requirement, total analgesic consumption, intraoperative opioid use, and hemodynamic parameters. By comparing these two interfascial plane blocks, this study aims to identify a more effective analgesic technique that improves postoperative pain control, enhances patient comfort, and facilitates early mobilization following mastectomy.

Read the detailed description

Postoperative pain following mastectomy surgery remains a significant clinical concern, as it negatively impacts patient comfort, delays recovery, and may prolong hospital stay. Effective pain management is essential not only to improve patient satisfaction but also to reduce complications associated with delayed mobilization. Although systemic opioids and other analgesics are frequently used, they are associated with adverse effects such as sedation, nausea, constipation, and risk of dependency. Therefore, regional anesthesia techniques have gained increasing importance as part of multimodal analgesia strategies.

Ultrasound-guided interfascial plane blocks, such as the serratus anterior plane (SAP) block and the serratus posterior superior intercostal plane (SPSIP) block, have been shown to provide effective analgesia for thoracic and breast surgeries by targeting similar dermatomal distributions. However, comparative data regarding their relative efficacy in mastectomy patients are limited. This study aims to compare these two techniques in terms of postoperative analgesia and recovery outcomes.

Female patients aged between 18 and 75 years, classified as ASA physical status I, II, or III, and scheduled for elective mastectomy will be included in the study after obtaining written informed consent. Patients will be randomly assigned into two groups.

In Group 1, patients will receive an ultrasound-guided SAP block using a linear probe under aseptic conditions. The block will be performed in the lateral decubitus position by advancing the needle between the second and seventh ribs to the plane beneath the serratus anterior muscle, and 30 mL of 0.25% bupivacaine will be administered.

In Group 2, patients will receive an ultrasound-guided SPSIP block under aseptic conditions in the sitting position. The needle will be inserted medially to the scapula between the second and seventh ribs, targeting the plane between the serratus posterior superior muscle and intercostal muscles, and 30 mL of 0.25% bupivacaine (maximum dose 2 mg/kg/day) will be administered.

All patients will undergo standardized general anesthesia, including induction with midazolam, lidocaine, propofol, fentanyl, and rocuronium, followed by maintenance with desflurane at 1 MAC. Standard intraoperative monitoring (heart rate, blood pressure, oxygen saturation, end-tidal CO₂, and ECG) will be applied. Intraoperative administration of paracetamol, tenoxicam, and granisetron will be performed routinely.

Hemodynamic parameters will be recorded at 30-minute intervals during surgery. Total intraoperative opioid consumption, duration of surgery, and anesthesia time will also be documented. At the end of surgery, neuromuscular blockade will be reversed with sugammadex.

Postoperative pain will be assessed by a blinded investigator using the Numeric Rating Scale (NRS) at 0, 30 minutes, and at 1, 2, 4, 8, 12, 24, 36, and 48 hours. Time to first analgesic requirement, additional analgesic use, and total consumption will be recorded.

Patients with NRS ≥4 will receive intravenous paracetamol as first-line rescue analgesia. If pain persists, intravenous opioid (1 mg/kg) will be administered as second-line rescue analgesia.

Secondary outcomes include postoperative complications, pain during first mobilization, and patient and surgeon satisfaction assessed using a 5-point Likert scale.

Statistical analysis will be performed using SPSS version 25. Normality of data will be assessed using Kolmogorov-Smirnov and Shapiro-Wilk tests. Parametric or non-parametric tests will be used accordingly. Independent samples t-test or Mann-Whitney U test will be used for comparisons between groups, while paired t-test or Wilcoxon test will be used for within-group comparisons. ANOVA or Kruskal-Wallis tests will be used for comparisons involving more than two groups. A p-value <0.05 will be considered statistically significant.

This study is expected to determine the comparative effectiveness of SAP and SPSIP blocks in reducing postoperative pain, minimizing analgesic consumption, and improving recovery outcomes in patients undergoing mastectomy.

Being tested
SAP Block, SPSIP Block
Keywords
Serratus Posterior Superior Intercostal Plane Block, Serratus Anterior Plane Block, Multimodal Analgesia, Mastectomy Surgery
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAP BlockProcedure or surgery

    Under ultrasound guidance with a linear probe, the needle is inserted along the posterior axillary line between the second and seventh ribs and advanced into the plane between the serratus anterior muscle and the rib surface. A total of 30 mL of 0.25% bupivacaine (maximum dose 2 mg/kg/day) is injected.

  • SPSIP BlockProcedure or surgery

    Under ultrasound guidance with a linear probe, the superomedial border of the scapula on the operative side is identified. The needle is inserted medial to the scapula between the second and seventh ribs and advanced into the interfascial plane between the serratus posterior superior muscle and the intercostal muscles. Subsequently, 30 mL of 0.25% bupivacaine (maximum dose 2 mg/kg/day) is administered.

Study groups in NCT07510269
Study groupRoleWhat they receive
SAPB GroupExperimentalPatients in this group will receive Serratus Anterior Plane Block for postoperative analgesia.
Receives: Procedure: SAP Block
SPSIPB GroupExperimentalPatients in this group will receive Serratus Posterior Superior Intercostal Plane Block for postoperative analgesia.
Receives: Procedure: SPSIP Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Pain Intensity

    Postoperative pain intensity and time to first analgesic requirement will be evaluated. Pain will be assessed using the Numeric Rating Scale (NRS, 0-10) at 0 and 30 minutes, and at 1, 2, 4, 8, 12, 24, 36, and 48 hours postoperatively, both at rest and during movement, by a blinded investigator

    Measured: Within 48 hours postoperatively

Secondary outcomes (8)
  1. Total Analgesic Consumption

    Total consumption of additional analgesics (paracetamol and opioid) will be recorded.

    Measured: Within 48 hours postoperatively

  2. Additional Analgesic Requirement

    The number of patients requiring additional analgesia and the frequency of administration will be recorded.

    Measured: Within 48 hours postoperatively

  3. Intraoperative Opioid Consumption

    The total amount of opioids administered intraoperatively will be recorded.

    Measured: During surgery

  4. Intraoperative mean arterial pressure (mmHg)

    Mean arterial pressure (mmHg) will be recorded at 30 minute intervals during surgery and summarized as mean values.

    Measured: Every 30 minutes intraoperatively

  5. Postoperative Complications

    Postoperative complications such as nausea, vomiting or other adverse events will be recorded.

    Measured: Within 48 hours postoperatively

  6. Pain During First Mobilization

    Pain during first mobilization will be assessed using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.

    Measured: Within 48 hours postoperatively

  7. Patient satisfaction score

    evaluated using a 5-point Likert scale (1=very dissatisfied, 5=very satisfied)

    Measured: At the 24th hour post-operation

  8. Surgeon satisfaction score

    The primary surgeon's satisfaction will the analgesia quality and ease of the procedure, evaluated using a 5-point Likert scale (1= very dissatisfied , 5= very satisfied)

    Measured: Within 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2026
  2. Study start15 Oct 2025
  3. Primary completion15 Sep 2026 (estimated)
  4. Study completion15 Oct 2026 (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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07510269
Sponsor's protocol ID
25AKD131
Status last verified
Mar 2026
First submitted
19 Mar 2026
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The individual participant data (IPD) will not be shared to protect patient privacy and confidentiality. The data collected for this study will only be used for the purposes of this specific research and will not be made available to other researchers to comply with institutional ethical guidelines.

Publications

  • Gupta K, Srikanth K, Girdhar KK, Chan V. Analgesic efficacy of ultrasound-guided paravertebral block versus serratus plane block for modified radical mastectomy: A randomised, controlled trial. Indian J Anaesth. 2017 May;61(5):381-386. doi: 10.4103/ija.IJA_62_17.

    PubMed 28584346
  • Aslan G, Avci O, Gundogdu O, Isbir AC, Ozdemir Kol I, Kaygusuz K, Gursoy S. The effect of postoperative serratus anterior plane block on postoperative analgesia in patients undergoing breast surgery. Turk J Surg. 2020 Dec 29;36(4):374-381. doi: 10.47717/turkjsurg.2020.4744. eCollection 2020 Dec.

    PubMed 33778397
  • Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.

    PubMed 36883093

Questions about this trial

What is this clinical trial studying?

A study testing SAP Block and SPSIP Block in people with Postoperative Pain and Nerve Block, run by Uludag University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain Intensity (time frame: Within 48 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07510269, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.

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