Quality of Recovery After MastectomyNCT07661212
Timing of Serratus Anterior Plane Block in Mastectomy Surgery
A study testing Ultrasound-Guided Serratus Anterior Plane Block and Bupivacaine in people with Quality of Recovery After Mastectomy and Serratus Anterior Plane Block, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain following mastectomy may adversely affect early mobilization, patient comfort, and overall quality of recovery. Serratus anterior plane block is an ultrasound-guided regional anesthesia technique that provides analgesia to the anterolateral thoracic wall and is increasingly used as part of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Quality of Recovery After Mastectomy, Serratus Anterior Plane Block, Postoperative Pain
- What is being tested?
- Ultrasound-Guided Serratus Anterior Plane Block and Bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 1 Oct 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 years or older
- Scheduled for elective unilateral mastectomy surgery
- Planned to undergo surgery under general anesthesia
- American Society of Anesthesiologists physical status I-III
- Willing and able to participate in the study
- Provision of written informed consent
Who cannot join
- Refusal to participate in the study
- Known allergy to local anesthetics planned for use in the study
- Chronic opioid use
- Current steroid or immunosuppressive therapy
- Presence of chronic inflammatory disease
- Surgical duration shorter than 30 minutes
Show all 14Show fewer
- Active infection
- Coagulopathy
- Infection at the planned block site
- Pregnancy or lactation
- Advanced hepatic failure or advanced renal failure
- Reoperation due to recurrent disease
- Inability to communicate adequately or to provide reliable pain scores
- Psychiatric or neurological condition limiting reliable completion of the QoR-15 questionnaire or Numeric Rating Scale assessments
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
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, 34147
Fatma Çiğdem ÖZAKIN, MD, +905464168250, f.cigdemulus@gmail.com
Fatma Çiğdem ÖZAKIN, MD
About this study
Official title: The Effect of Serratus Anterior Plane Block Timing on Postoperative Quality of Recovery, Postoperative Pain, and Inflammatory Response in Elective Unilateral Mastectomy Surgery: A Prospective Randomized Controlled Clinical Trial
Postoperative pain following mastectomy may adversely affect early mobilization, patient comfort, and overall quality of recovery. Serratus anterior plane block is an ultrasound-guided regional anesthesia technique that provides analgesia to the anterolateral thoracic wall and is increasingly used as part of multimodal analgesia for breast surgery. Although the analgesic efficacy of serratus anterior plane block has been investigated in breast surgery, the clinical impact of the timing of block administration remains insufficiently defined.
This prospective, randomized, controlled, patient and assessor blinded clinical trial will compare two different timings of ultrasound-guided serratus anterior plane block in adult female patients undergoing elective unilateral mastectomy under general anesthesia. Participants will be randomized to receive serratus anterior plane block either after induction of general anesthesia and before surgical incision, or after completion of surgery and before extubation. In both groups, the block will be performed under ultrasound guidance using 25 mL of 0.25% bupivacaine.
Read more
The primary outcome is postoperative quality of recovery at 24 hours, assessed using the Quality of Recovery-15 questionnaire. Secondary outcomes include postoperative pain scores at predefined time points during the first 24 postoperative hours, intraoperative remifentanil consumption, postoperative opioid and non-opioid analgesic requirements, time to first analgesic requirement, postoperative nausea and vomiting, length of hospital stay, complications, inflammatory response markers including CRP and neutrophil-to-lymphocyte ratio, and intraoperative hemodynamic variables.
The study is planned to enroll 80 participants at a single tertiary training and research hospital. The findings are expected to clarify whether preincisional administration of serratus anterior plane block provides superior postoperative recovery, analgesic efficacy, and modulation of inflammatory response compared with administration at the end of surgery.
- Conditions
- Quality of Recovery After Mastectomy, Serratus Anterior Plane Block, Postoperative Pain, Mastectomy
- Being tested
- Ultrasound-Guided Serratus Anterior Plane Block, Bupivacaine
- Keywords
- Serratus Anterior Plane Block, Postoperative Pain, Mastectomy, Regional Anesthesia, Pain Management, Bupivacaine, Quality of Recovery, CRP, Neutrophil-Lymphocyte Ratio, Inflammation, Breast Surgery
- Medical subject headings
- Pain, Postoperative, Agnosia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Serratus Anterior Plane BlockProcedure or surgery
Also called SAP Block
Ultrasound-guided serratus anterior plane block will be performed under general anesthesia on the operative side. With the patient in the supine position and the ipsilateral arm abducted, a high-frequency linear ultrasound probe will be placed at the midaxillary line around the fourth to fifth intercostal level. After identification of the latissimus dorsi and serratus anterior muscles, the block needle will be advanced using an in-plane technique, and 25 mL of 0.25% bupivacaine will be injected into the fascial plane between these muscles after negative aspiration. In the preincisional arm, the block will be performed after induction of general anesthesia and before surgical incision. In the end-of-surgery arm, the same block will be performed after completion of surgery and before extubation.
BupivacaineDrug
Bupivacaine 0.25%, 25 mL (62.5 mg), will be administered as a single ultrasound-guided injection into the serratus anterior plane on the operative side. In the preincisional arm, administration will occur after induction of general anesthesia and before surgical incision. In the end-of-surgery arm, administration will occur after completion of surgery and before extubation.
| Study group | Role | What they receive |
|---|---|---|
| Preincisional SAP Block | Experimental | Participants assigned to this arm will receive ultrasound-guided serratus anterior plane block after induction of general anesthesia and before surgical incision. The block will be performed on the operative side using 25 mL of 0.25% bupivacaine, in addition to standardized general anesthesia and postoperative analgesic management. Receives: Procedure: Ultrasound-Guided Serratus Anterior Plane Block; Drug: Bupivacaine |
| End-of-Surgery SAP Block | Experimental | Participants assigned to this arm will receive ultrasound-guided serratus anterior plane block after completion of surgery and before extubation. The block will be performed on the operative side using 25 mL of 0.25% bupivacaine, in addition to standardized general anesthesia and postoperative analgesic management. Receives: Procedure: Ultrasound-Guided Serratus Anterior Plane Block; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Quality of Recovery at 24 Hours
Postoperative quality of recovery will be assessed using the Quality of Recovery-15 questionnaire. The postoperative 24-hour QoR-15 score will be compared between the preincisional serratus anterior plane block group and the end-of-surgery serratus anterior plane block group. Higher scores indicate better quality of recovery.
Measured: 24 hours after surgery
Secondary outcomes (14)
Resting Postoperative Pain Scores
Resting pain intensity will be assessed using the Numeric Rating Scale at postoperative 0, 1, 4, 8, 12, 16, 20, and 24 hours.
Measured: Postoperative 0 to 24 hours
Intraoperative Remifentanil Consumption
Total intraoperative remifentanil consumption will be recorded and compared between groups.
Measured: During surgery
Postoperative Opioid Consumption
Total opioid consumption during the first 24 postoperative hours will be calculated based on tramadol use.
Measured: Postoperative 0 to 24 hours
Postoperative Non-Opioid Analgesic Consumption
Total non-opioid analgesic consumption during the first 24 postoperative hours will be recorded, including paracetamol use.
Measured: Postoperative 0 to 24 hours
Time to First Analgesic Requirement
The time from admission to the postoperative recovery unit to the first requirement for rescue analgesia will be recorded.
Measured: Postoperative 0 to 24 hours
Postoperative Nausea and Vomiting
The occurrence of postoperative nausea and vomiting will be assessed during the first 24 postoperative hours.
Measured: Postoperative 0 to 24 hours
Length of Hospital Stay
Length of hospital stay will be recorded as the number of days from surgery to discharge.
Measured: From surgery until hospital discharge, assessed up to 30 days.
C-Reactive Protein Level
Serum C-reactive protein concentration will be measured as a marker of postoperative inflammatory response and reported in mg/L.
Measured: Postoperative 6 hours
White Blood Cell Count
Absolute neutrophil count will be measured from the complete blood count and reported in ×10^9/L.
Measured: Postoperative 6 hours
Absolute Neutrophil Count
Absolute neutrophil count will be measured from the complete blood count and reported in ×10^9/L.
Measured: Postoperative 6 hours
Absolute Lymphocyte Count
Absolute lymphocyte count will be measured from the complete blood count and reported in ×10^9/L.
Measured: Postoperative 6 hours
Neutrophil-to-Lymphocyte Ratio
The neutrophil-to-lymphocyte ratio will be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count. The ratio is unitless.
Measured: Postoperative 6 hours
Intraoperative Heart Rate
Heart rate will be recorded in beats per minute during the intraoperative period and compared between groups.
Measured: From induction of general anesthesia to completion of surgery
Intraoperative Mean Arterial Pressure
Mean arterial pressure will be recorded in mmHg during the intraoperative period and compared between groups.
Measured: From induction of general anesthesia to completion of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Quality of Recovery After MastectomyStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma Cigdem Ozakin, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Fatma Çiğdem ÖZAKIN, MD, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661212
- Sponsor's protocol ID
- 2026/240
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang S, Shi J, Dai Y, Zhang J, Liu Q, Yang P, Zhu N. The effect of different nerve block strategies on the quality of post-operative recovery in breast cancer patients: A randomized controlled study. Eur J Pain. 2024 Jan;28(1):166-173. doi: 10.1002/ejp.2178. Epub 2023 Sep 1.
PubMed 37655864Yao Y, Li J, Hu H, Xu T, Chen Y. Ultrasound-guided serratus plane block enhances pain relief and quality of recovery after breast cancer surgery: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jun;36(6):436-441. doi: 10.1097/EJA.0000000000001004.
PubMed 31021882Elsabeeny WY, Shehab NN, Wadod MA, Elkady MA. Perioperative Analgesic Modalities for Breast Cancer Surgeries: A Prospective Randomized Controlled Trial. J Pain Res. 2020 Nov 12;13:2885-2894. doi: 10.2147/JPR.S274808. eCollection 2020.
PubMed 33209056
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Serratus Anterior Plane Block Timing on Postoperative Quality of Recovery, Postoperative Pain, and Inflammatory Response in Elective Unilateral Mastectomy Surgery: A Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07661212
- Acronym / sponsor ID
- 2026/240
- Conditions
- Quality of Recovery After Mastectomy, Serratus Anterior Plane Block, Postoperative Pain, Mastectomy
- Keywords
- Serratus Anterior Plane Block, Postoperative Pain, Mastectomy, Regional Anesthesia, Pain Management, Bupivacaine, Quality of Recovery, CRP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 22 Jun 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.
Postoperative pain following mastectomy may adversely affect early mobilization, patient comfort, and overall quality of recovery. Serratus anterior plane block is an ultrasound-guided regional anesthesia technique that provides analgesia to the anterolateral thoracic wall and is increasingly used as part of multimodal analgesia for breast surgery. Although the analgesic efficacy of serratus anterior plane block has been investigated in breast surgery, the clinical impact of the timing of block administration remains insufficiently defined.
This prospective, randomized, controlled, patient and assessor blinded clinical trial will compare two different timings of ultrasound-guided serratus anterior plane block in adult female patients undergoing elective unilateral mastectomy under general anesthesia. Participants will be randomized to receive serratus anterior plane block either after induction of general anesthesia and before surgical incision, or after completion of surgery and before extubation. In both groups, the block will be performed under ultrasound guidance using 25 mL of 0.25% bupivacaine.
The primary outcome is postoperative quality of recovery at 24 hours, assessed using the Quality of Recovery-15 questionnaire. Secondary outcomes include postoperative pain scores at predefined time points during the first 24 postoperative hours, intraoperative remifentanil consumption, postoperative opioid and non-opioid analgesic requirements, time to first analgesic requirement, postoperative nausea and vomiting, length of hospital stay, complications, inflammatory response markers including CRP and neutrophil-to-lymphocyte ratio, and intraoperative hemodynamic variables.
The study is planned to enroll 80 participants at a single tertiary training and research hospital. The findings are expected to clarify whether preincisional administration of serratus anterior plane block provides superior postoperative recovery, analgesic efficacy, and modulation of inflammatory response compared with administration at the end of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preincisional SAP Block | Experimental | Procedure: Ultrasound-Guided Serratus Anterior Plane Block, Drug: BupivacaineParticipants assigned to this arm will receive ultrasound-guided serratus anterior plane block after induction of general anesthesia and before surgical incision. The block will be performed on the operative side using 25 mL of 0.25% bupivacaine, in addition to standardized general anesthesia and postoperative analgesic management. |
| End-of-Surgery SAP Block | Experimental | Procedure: Ultrasound-Guided Serratus Anterior Plane Block, Drug: BupivacaineParticipants assigned to this arm will receive ultrasound-guided serratus anterior plane block after completion of surgery and before extubation. The block will be performed on the operative side using 25 mL of 0.25% bupivacaine, in addition to standardized general anesthesia and postoperative analgesic management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients aged 18 years or older
- Scheduled for elective unilateral mastectomy surgery
- Planned to undergo surgery under general anesthesia
- American Society of Anesthesiologists physical status I-III
- Willing and able to participate in the study
Key exclusion criteria (14 listed)
- Refusal to participate in the study
- Known allergy to local anesthetics planned for use in the study
- Chronic opioid use
- Current steroid or immunosuppressive therapy
- Presence of chronic inflammatory disease
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 |
|---|---|---|
| Ultrasound-Guided Serratus Anterior Plane BlockAlso: SAP BlockUltrasound-guided serratus anterior plane block will be performed under general anesthesia on the operative side. With the patient in the supine position and the ipsilateral arm abducted, a high-frequency linear ultrasound probe will be placed at the midaxillary line around the fourth to fifth intercostal level. After identification of the latissimus dorsi and serratus anterior muscles, the block needle will be advanced using an in-plane technique, and 25 mL of 0.25% bupivacaine will be injected into the fascial plane between these muscles after negative aspiration. In the preincisional arm, the block will be performed after induction of general anesthesia and before surgical incision. In the end-of-surgery arm, the same block will be performed after completion of surgery and before extubation. | Procedure or surgery | End-of-Surgery SAP Block, Preincisional SAP Block |
| BupivacaineBupivacaine 0.25%, 25 mL (62.5 mg), will be administered as a single ultrasound-guided injection into the serratus anterior plane on the operative side. In the preincisional arm, administration will occur after induction of general anesthesia and before surgical incision. In the end-of-surgery arm, administration will occur after completion of surgery and before extubation. | Drug | End-of-Surgery SAP Block, Preincisional SAP Block |
Primary outcome
Postoperative Quality of Recovery at 24 Hours
Time frame: 24 hours after surgery
Postoperative quality of recovery will be assessed using the Quality of Recovery-15 questionnaire. The postoperative 24-hour QoR-15 score will be compared between the preincisional serratus anterior plane block group and the end-of-surgery serratus anterior plane block group. Higher scores indicate better quality of recovery.
14 secondary outcomes
Resting Postoperative Pain Scores
Time frame: Postoperative 0 to 24 hours
Intraoperative Remifentanil Consumption
Time frame: During surgery
Postoperative Opioid Consumption
Time frame: Postoperative 0 to 24 hours
Postoperative Non-Opioid Analgesic Consumption
Time frame: Postoperative 0 to 24 hours
Time to First Analgesic Requirement
Time frame: Postoperative 0 to 24 hours
Postoperative Nausea and Vomiting
Time frame: Postoperative 0 to 24 hours
Length of Hospital Stay
Time frame: From surgery until hospital discharge, assessed up to 30 days.
C-Reactive Protein Level
Time frame: Postoperative 6 hours
White Blood Cell Count
Time frame: Postoperative 6 hours
Absolute Neutrophil Count
Time frame: Postoperative 6 hours
Absolute Lymphocyte Count
Time frame: Postoperative 6 hours
Neutrophil-to-Lymphocyte Ratio
Time frame: Postoperative 6 hours
Intraoperative Heart Rate
Time frame: From induction of general anesthesia to completion of surgery
Intraoperative Mean Arterial Pressure
Time frame: From induction of general anesthesia to completion of surgery
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 22 Jun 2026.
- Background: PubMed 37655864Wang S, Shi J, Dai Y, Zhang J, Liu Q, Yang P, Zhu N. The effect of different nerve block strategies on the quality of post-operative recovery in breast cancer patients: A randomized controlled study. Eur J Pain. 2024 Jan;28(1):166-173. doi: 10.1002/ejp.2178. Epub 2023 Sep 1.
- Background: PubMed 31021882Yao Y, Li J, Hu H, Xu T, Chen Y. Ultrasound-guided serratus plane block enhances pain relief and quality of recovery after breast cancer surgery: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jun;36(6):436-441. doi: 10.1097/EJA.0000000000001004.
- Background: PubMed 33209056Elsabeeny WY, Shehab NN, Wadod MA, Elkady MA. Perioperative Analgesic Modalities for Breast Cancer Surgeries: A Prospective Randomized Controlled Trial. J Pain Res. 2020 Nov 12;13:2885-2894. doi: 10.2147/JPR.S274808. eCollection 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Quality of Recovery After Mastectomy
Active, not recruitingObservational study
Quality of Recovery From Mastectomy With and Without PECS Blocks
Post Operative Pain, Quality of Recovery After Mastectomy
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.
Fatma Çiğdem ÖZAKIN, MD principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Serratus Anterior Plane Block and Bupivacaine in people with Quality of Recovery After Mastectomy and Serratus Anterior Plane Block, run by Bakirkoy Dr. Sadi Konuk Research and Training 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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 22 Jun 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?
Contact Fatma Çiğdem ÖZAKIN, MD (+905464168250, f.cigdemulus@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Quality of Recovery at 24 Hours (time frame: 24 hours after surgery). 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 NCT07661212, 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 22 Jun 2026.