Postoperative Pain ManagementDSAPvsSSAPNCT07502846
Superficial vs Deep Serratus Anterior Plane Block for Analgesia After Mammoplasty
A study testing Superficial Serratus Anterior Plane Block and Deep Serratus Anterior Plane Block in people with Postoperative Pain Management and Analgesia, Postoperative, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The serratus anterior plane block (SAPB) is an ultrasound-guided fascial plane block used for perioperative analgesia in thoracic and breast surgeries. This technique involves the injection of local anesthetic into either the superficial or deep interfascial plane around the serratus anterior muscle at the… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Postoperative Pain Management, Analgesia, Postoperative, Breast Surgery
- What is being tested?
- Superficial Serratus Anterior Plane Block and Deep Serratus Anterior Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 1 Apr 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 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam & Sakura City Hospital
Istanbul, Basaksehir, 34480
About this study
Official title: Comparison of the Postoperative Analgesic Efficacy of Superficial and Deep Serratus Anterior Plane Blocks in Patients Undergoing Mammoplasty Surgery
The serratus anterior plane block (SAPB) is an ultrasound-guided fascial plane block used for perioperative analgesia in thoracic and breast surgeries. This technique involves the injection of local anesthetic into either the superficial or deep interfascial plane around the serratus anterior muscle at the mid-axillary line, targeting the lateral cutaneous branches of the intercostal nerves and providing analgesia to the anterolateral thoracic wall. The present prospective, comparative, single-blind clinical study aims to compare the postoperative analgesic efficacy of superficial and deep SAPB techniques in patients undergoing mammoplasty surgery. The primary objective is to evaluate total opioid consumption within the first 24 hours postoperatively,while secondary outcomes include postoperative pain scores,additional analgesic requirements, postoperative nausea and vomiting, patient satisfaction, time to first mobilization, and vital signs within the first 24 hours postoperatively. The results of this study may help determine the more effective SAPB technique for improving postoperative pain control and reducing opioid use in patients undergoing mammoplasty.
Read the 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.
- Conditions
- Postoperative Pain Management, Analgesia, Postoperative, Breast Surgery, Mammoplasty Patient, Opioid Consumption
- Being tested
- Superficial Serratus Anterior Plane Block, Deep Serratus Anterior Plane Block
- Keywords
- Serratus Anterior Plane Block, SAPB, Mammoplasty, Breast Surgery, Postoperative Analgesia, Postoperative Pain, Opioid Consumption
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superficial Serratus Anterior Plane BlockProcedure or surgery
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.
Deep Serratus Anterior Plane BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Superficial Serratus Anterior Plane Block | Experimental | Patients undergoing mammoplasty surgery who receive an ultrasound-guided superficial serratus anterior plane block for postoperative analgesia. Receives: Procedure: Superficial Serratus Anterior Plane Block |
| Deep Serratus Anterior Plane Block | Experimental | Patients undergoing mammoplasty surgery who receive an ultrasound-guided deep serratus anterior plane block for postoperative analgesia. Receives: Procedure: Deep Serratus Anterior Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
Total opioid consumption required for postoperative analgesia in patients undergoing mammoplasty surgery.
Measured: Within the first 24 hours postoperatively
Secondary outcomes (9)
Postoperative pain score (Numeric Rating Scale)
Postoperative pain intensity assessed using the Numeric Rating Scale (0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: Within the first 24 hours postoperatively
Additional analgesic requirement
Requirement for rescue analgesia during the postoperative period.
Measured: Within the first 24 hours postoperatively
Postoperative nausea and vomiting
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.
Measured: Within the first 24 hours postoperatively
Patient satisfaction score and Quality of Recovery Score (QoR-15)
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.
Measured: Within the first 24 hours postoperatively
Time to first mobilization
Time from the end of surgery to the first postoperative mobilization.
Measured: Within the first 24 hours postoperatively
Postoperative Blood pressure
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.
Measured: Within the first 24 hours postoperatively
Postoperative heart rate
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.
Measured: Postoperative 24 hours
Postoperative oxygen saturation levels
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.
Measured: Postoperative 24 hours
Length of hospital stay
Duration of hospitalization from the time of surgery until hospital discharge, measured in days.
Measured: From surgery date until hospital discharge, assessed up to 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start15 Nov 2024
- Primary completion22 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muzaffer GENCER, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502846
- Sponsor's protocol ID
- 46-2025
- Acronym
- DSAPvsSSAP
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23923989Bartels 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.
PubMed 26824844von 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.
PubMed 20727797Gerbershagen 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.
PubMed 23392233
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Analgesic Efficacy of Superficial and Deep Serratus Anterior Plane Blocks in Patients Undergoing Mammoplasty Surgery
- ClinicalTrials.gov ID
- NCT07502846
- Acronym / sponsor ID
- DSAPvsSSAP / 46-2025
- Conditions
- Postoperative Pain Management, Analgesia, Postoperative, Breast Surgery, Mammoplasty Patient, Opioid Consumption
- Keywords
- Serratus Anterior Plane Block, SAPB, Mammoplasty, Breast Surgery, Postoperative Analgesia, Postoperative Pain, Opioid Consumption
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 22 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The serratus anterior plane block (SAPB) is an ultrasound-guided fascial plane block used for perioperative analgesia in thoracic and breast surgeries. This technique involves the injection of local anesthetic into either the superficial or deep interfascial plane around the serratus anterior muscle at the mid-axillary line, targeting the lateral cutaneous branches of the intercostal nerves and providing analgesia to the anterolateral thoracic wall. The present prospective, comparative, single-blind clinical study aims to compare the postoperative analgesic efficacy of superficial and deep SAPB techniques in patients undergoing mammoplasty surgery. The primary objective is to evaluate total opioid consumption within the first 24 hours postoperatively,while secondary outcomes include postoperative pain scores,additional analgesic requirements, postoperative nausea and vomiting, patient satisfaction, time to first mobilization, and vital signs within the first 24 hours postoperatively. The results of this study may help determine the more effective SAPB technique for improving postoperative pain control and reducing opioid use in patients undergoing mammoplasty.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superficial Serratus Anterior Plane Block | Experimental | Procedure: Superficial Serratus Anterior Plane BlockPatients undergoing mammoplasty surgery who receive an ultrasound-guided superficial serratus anterior plane block for postoperative analgesia. |
| Deep Serratus Anterior Plane Block | Experimental | Procedure: Deep Serratus Anterior Plane BlockPatients undergoing mammoplasty surgery who receive an ultrasound-guided deep serratus anterior plane block for postoperative analgesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superficial Serratus Anterior Plane BlockUltrasound-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. | Procedure or surgery | Superficial Serratus Anterior Plane Block |
| Deep Serratus Anterior Plane BlockUltrasound-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. | Procedure or surgery | Deep Serratus Anterior Plane Block |
Primary outcome
Total opioid consumption
Time frame: Within the first 24 hours postoperatively
Total opioid consumption required for postoperative analgesia in patients undergoing mammoplasty surgery.
9 secondary outcomes
Postoperative pain score (Numeric Rating Scale)
Time frame: Within the first 24 hours postoperatively
Additional analgesic requirement
Time frame: Within the first 24 hours postoperatively
Postoperative nausea and vomiting
Time frame: Within the first 24 hours postoperatively
Patient satisfaction score and Quality of Recovery Score (QoR-15)
Time frame: Within the first 24 hours postoperatively
Time to first mobilization
Time frame: Within the first 24 hours postoperatively
Postoperative Blood pressure
Time frame: Within the first 24 hours postoperatively
Postoperative heart rate
Time frame: Postoperative 24 hours
Postoperative oxygen saturation levels
Time frame: Postoperative 24 hours
Length of hospital stay
Time frame: From surgery date until hospital discharge, assessed up to 7 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Background: PubMed 23923989Blanco 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.
- Background: PubMed 26824844Bartels 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.
- Background: PubMed 20727797von 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.
- Background: PubMed 23392233Gerbershagen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superficial Serratus Anterior Plane Block and Deep Serratus Anterior Plane Block in people with Postoperative Pain Management and Analgesia, Postoperative, run by Başakşehir Çam & Sakura City Hospital 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 11 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: under way, not looking for participants, as of the sponsor's last update on 31 Mar 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid consumption (time frame: Within the first 24 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 NCT07502846, which also lists 4 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 31 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.