- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07510269
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
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nilüfer
-
Bursa, Nilüfer, Turkey (Türkiye), 16235
- Recruiting
- Bursa Uludag University Hospital
-
Contact:
- Muhammed A MOL, MD
- Phone Number: +902242954476 +90 506 253 62 54
- Email: malihanmol@uludag.edu.tr
-
Contact:
- Ali H Colak, MD
- Phone Number: +902242953131 +90 506 560 35 17
- Email: alihaydarcolak@uludag.edu.tr
-
Principal Investigator:
- Selcan Akesen, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SAPB Group
Patients in this group will receive Serratus Anterior Plane Block for postoperative analgesia.
|
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.
|
|
Experimental: SPSIPB Group
Patients in this group will receive Serratus Posterior Superior Intercostal Plane Block for postoperative analgesia.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Intensity
Time Frame: Within 48 hours postoperatively
|
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
|
Within 48 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Analgesic Consumption
Time Frame: Within 48 hours postoperatively
|
Total consumption of additional analgesics (paracetamol and opioid) will be recorded.
|
Within 48 hours postoperatively
|
|
Additional Analgesic Requirement
Time Frame: Within 48 hours postoperatively
|
The number of patients requiring additional analgesia and the frequency of administration will be recorded.
|
Within 48 hours postoperatively
|
|
Intraoperative Opioid Consumption
Time Frame: During surgery
|
The total amount of opioids administered intraoperatively will be recorded.
|
During surgery
|
|
Intraoperative mean arterial pressure (mmHg)
Time Frame: Every 30 minutes intraoperatively
|
Mean arterial pressure (mmHg) will be recorded at 30 minute intervals during surgery and summarized as mean values.
|
Every 30 minutes intraoperatively
|
|
Postoperative Complications
Time Frame: Within 48 hours postoperatively
|
Postoperative complications such as nausea, vomiting or other adverse events will be recorded.
|
Within 48 hours postoperatively
|
|
Pain During First Mobilization
Time Frame: Within 48 hours postoperatively
|
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.
|
Within 48 hours postoperatively
|
|
Patient satisfaction score
Time Frame: At the 24th hour post-operation
|
evaluated using a 5-point Likert scale (1=very dissatisfied, 5=very satisfied)
|
At the 24th hour post-operation
|
|
Surgeon satisfaction score
Time Frame: Within 24 hours postoperatively
|
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)
|
Within 24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25AKD131
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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