- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07502846
Superficial vs Deep Serratus Anterior Plane Block for Analgesia After Mammoplasty (DSAPvsSSAP)
Comparison of the Postoperative Analgesic Efficacy of Superficial and Deep Serratus Anterior Plane Blocks in Patients Undergoing Mammoplasty Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Mammoplasty surgery is frequently associated with moderate to severe postoperative pain. Inadequate postoperative pain control may negatively affect patient recovery, delay mobilization, and increase opioid consumption. Traditionally, opioids have been widely used for the management of postoperative pain; however, opioid-related adverse effects and the growing concerns regarding opioid misuse have encouraged the use of multimodal analgesia strategies. Regional anesthesia techniques have therefore become an essential component of postoperative pain management and Enhanced Recovery After Surgery (ERAS) protocols.
Peripheral nerve blocks provide effective analgesia, reduce opioid consumption, and improve patient comfort during the postoperative period. In recent years, ultrasound-guided fascial plane blocks have gained increasing popularity due to their relative simplicity, safety, and favorable balance between sensory and motor blockade.
The serratus anterior plane block (SAPB), first described by Rafael Blanco in 2013, is an ultrasound-guided regional anesthesia technique used for analgesia in thoracic and breast surgeries. In this technique, local anesthetic is injected either into the superficial plane between the latissimus dorsi and serratus anterior muscles or into the deep plane between the serratus anterior muscle and the ribs at the mid-axillary line. This block targets the lateral cutaneous branches of the intercostal nerves and provides analgesia to the anterolateral thoracic wall.
Although SAPB has been increasingly used in breast surgeries, there is limited evidence comparing the analgesic efficacy of superficial and deep SAPB techniques in mammoplasty procedures. Therefore, further studies are needed to determine which technique provides superior postoperative analgesia and reduces opioid consumption more effectively.
This prospective, comparative, single-blind clinical study aims to compare the postoperative analgesic effectiveness of superficial and deep serratus anterior plane block techniques in patients undergoing mammoplasty surgery. Adult female patients aged 18-75 years with ASA physical status I-III scheduled for elective mammoplasty surgery will be included in the study. After ultrasound-guided SAPB administration, postoperative opioid consumption within the first 24 hours,pain scores,additional analgesic requirements, vital parameters, ,postoperative nausea and vomiting, patient satisfaction scores, Quality of postoperative recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire,time to first mobilization, and the length of hospital stay will be recorded and analyzed.
The results of this study are expected to contribute to the optimization of postoperative pain management strategies in mammoplasty surgery by identifying the more effective SAPB technique for reducing postoperative pain and opioid consumption.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Basaksehir
-
Istanbul, Basaksehir, Turkey (Türkiye), 34480
- Başakşehir Çam & Sakura City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female patients aged 18-75 years
- ASA physical status I-III
- Patients scheduled for elective mammoplasty surgery (unilateral or bilateral)
- Patients who voluntarily agree to participate in the study and provide informed consent
Exclusion Criteria:
- ASA physical status IV or higher
- Patients who refuse to participate in the study
- Patients who cannot provide informed consent due to language barriers
- Pregnant patients
- Active infection at the block application site
- Previous surgery affecting the anatomical integrity of the block area
- Known allergy to local anesthetic agents
- Patients with chronic pain or regular analgesic use
- Patients with coagulation disorders
- Patients with neurological or psychiatric disorders affecting pain perception or those using regular antipsychotic or antidepressant medications
- Body mass index (BMI) > 40 kg/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: Superficial Serratus Anterior Plane Block
Patients undergoing mammoplasty surgery who receive an ultrasound-guided superficial serratus anterior plane block for postoperative analgesia.
|
Ultrasound-guided superficial serratus anterior plane block performed at the mid-axillary line by injecting bupivacaine between the latissimus dorsi and serratus anterior muscles to provide postoperative analgesia in patients undergoing mammoplasty surgery.
|
|
Experimental: Deep Serratus Anterior Plane Block
Patients undergoing mammoplasty surgery who receive an ultrasound-guided deep serratus anterior plane block for postoperative analgesia.
|
Ultrasound-guided deep serratus anterior plane block performed at the mid-axillary line by injecting bupivacaine between the serratus anterior muscle and the ribs to provide postoperative analgesia in patients undergoing mammoplasty surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total opioid consumption
Time Frame: Within the first 24 hours postoperatively
|
Total opioid consumption required for postoperative analgesia in patients undergoing mammoplasty surgery.
|
Within the first 24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain score (Numeric Rating Scale)
Time Frame: Within the first 24 hours postoperatively
|
Postoperative pain intensity assessed using the Numeric Rating Scale (0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.
|
Within the first 24 hours postoperatively
|
|
Additional analgesic requirement
Time Frame: Within the first 24 hours postoperatively
|
Requirement for rescue analgesia during the postoperative period.
|
Within the first 24 hours postoperatively
|
|
Postoperative nausea and vomiting
Time Frame: Within the first 24 hours postoperatively
|
Occurrence of postoperative nausea and vomiting during the postoperative period.Nausea-vomiting descriptive scale (0: none, 1: mild nausea, 2: nausea, 3: vomiting once, 4: vomiting more than once) will be noted and 0.1 mg/kg IV ondansetron will be administered for scores of 2 and above.
|
Within the first 24 hours postoperatively
|
|
Patient satisfaction score and Quality of Recovery Score (QoR-15)
Time Frame: Within the first 24 hours postoperatively
|
Patient satisfaction with postoperative pain management assessed using a four-point scale (1 = not satisfied, 4 = very satisfied). Quality of postoperative recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire. The QoR-15 is a validated patient-reported outcome measure evaluating postoperative recovery across multiple domains, with scores ranging from 0 to 150, where higher scores indicate better recovery. |
Within the first 24 hours postoperatively
|
|
Time to first mobilization
Time Frame: Within the first 24 hours postoperatively
|
Time from the end of surgery to the first postoperative mobilization.
|
Within the first 24 hours postoperatively
|
|
Postoperative Blood pressure
Time Frame: Within the first 24 hours postoperatively
|
Participants' blood pressure (mmHg) will be monitored for 24 hours: in the operating room before the serratus anterior plane block and after block application, and postoperatively at 0, 1, 6, 12, and 24 hours.
|
Within the first 24 hours postoperatively
|
|
Postoperative heart rate
Time Frame: Postoperative 24 hours
|
Participants' heart rate (bpm) will be monitored for 24 hours: in the operating room before the serratus anterior plane block and after block application, and postoperatively at 0, 1, 6, 12, and 24 hours.
|
Postoperative 24 hours
|
|
Postoperative oxygen saturation levels
Time Frame: Postoperative 24 hours
|
Participants' oxygen saturation (SpO₂, %) will be monitored for 24 hours: in the operating room before the serratus anterior plane block and after block application, and postoperatively at 0, 1, 6, 12, and 24 hours.
|
Postoperative 24 hours
|
|
Length of hospital stay
Time Frame: From surgery date until hospital discharge, assessed up to 7 days.
|
Duration of hospitalization from the time of surgery until hospital discharge, measured in days.
|
From surgery date until hospital discharge, assessed up to 7 days.
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.
- Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
- Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
- von Sperling ML, Hoimyr H, Finnerup K, Jensen TS, Finnerup NB. Persistent pain and sensory changes following cosmetic breast augmentation. Eur J Pain. 2011 Mar;15(3):328-32. doi: 10.1016/j.ejpain.2010.07.004. Epub 2010 Aug 19.
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
- 46-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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