Postoperative PainNCT07561853
Serratus Posterior Superior vs Erector Spinae Plane Block for Breast Surgery
A study testing Serratus posterior superior intercostal plane block and Erector Spinae Plane Block in people with Postoperative Pain, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain after mastectomy remains a significant clinical problem that may impair patient comfort and delay early rehabilitation, potentially affecting functional recovery. Various analgesic techniques are used to manage postoperative pain. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Serratus posterior superior intercostal plane block and Erector Spinae Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 15 Dec 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female Gender
- Mastectomy operation
- 25-65 years
- American Society Anestheosiology Physical Status I-III
Who cannot join
- American Society Anestheosiology Physical Status IV
- Alcohol or substance abuse
- Known allergy to local anesthetics or opioids
- Severe psychiatric disorders
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
- Recruiting
Sakarya University-Anesthesiology and Reanimation Department
Sakarya
Mehmet Gökhan Küçük, MD, +905523940727, mgokhank09@gmail.com
About this study
Official title: Comparison of Serratus Posterior Superior Intercostal Plane Block and Erector Spinae Plane Block in Breast Surgery in Terms of Ease of Application and Patient Comfort
Postoperative pain after mastectomy remains a significant clinical problem that may impair patient comfort and delay early rehabilitation, potentially affecting functional recovery. Various analgesic techniques are used to manage postoperative pain. This study aims to compare serratus posterior superior intercostal plane block and erector spinae plane block, which are routinely used in our clinic for postoperative analgesia in patients undergoing mastectomy, in terms of ease of application and patient comfort.
Read the detailed description
Postoperative pain following mastectomy is a common and clinically significant issue that not only reduces patient comfort but may also hinder early mobilization and rehabilitation, thereby negatively impacting overall functional outcomes. Effective postoperative analgesia is therefore a key component of perioperative care in breast surgery.
A variety of analgesic techniques, including systemic analgesics and regional anesthesia methods, are currently employed to manage postoperative pain. Among these, ultrasound-guided fascial plane blocks have gained increasing popularity due to their relative safety, simplicity, and effectiveness. The serratus posterior superior intercostal plane (SPSIP) block and the erector spinae plane (ESP) block are two such regional techniques used for thoracic analgesia.
In our clinical practice, both SPSIP and ESP blocks are routinely used for patients undergoing mastectomy. However, comparative data regarding their ease of application and impact on patient comfort are limited. Ease of application is an important consideration for anesthesiologists, particularly in busy clinical settings, while patient comfort during block placement is a critical but often underreported outcome.
The primary aim of this study is to compare SPSIP block and ESP block in patients undergoing mastectomy in terms of ease of application and patient comfort during the procedure. Secondary considerations may include block-related characteristics and their contribution to postoperative recovery.
- Conditions
- Postoperative Pain
- Being tested
- Serratus posterior superior intercostal plane block, Erector Spinae Plane Block
- Keywords
- Serratus Posterior Superior Intercostal Plane Block, Erector Spinae Plane Block, Mastectomy, Postoperative Pain, Fascial Plane Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus posterior superior intercostal plane blockProcedure or surgery
Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block for postoperative analgesia following mastectomy. The block will be performed under standardized conditions prior to surgery according to the study protocol.
Erector Spinae Plane BlockProcedure or surgery
Participants in this group will receive an ultrasound-guided erector spinae plane (ESP) block for postoperative analgesia following mastectomy. The block will be performed under standardized conditions prior to surgery according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block Group | Experimental | Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block for postoperative analgesia following mastectomy. The block will be performed under standardized conditions prior to surgery according to the study protocol. Receives: Procedure: Serratus posterior superior intercostal plane block |
| Erector Spinae Plane Block Group | Experimental | Participants in this group will receive an ultrasound-guided erector spinae plane (ESP) block for postoperative analgesia following mastectomy. The block will be performed under standardized conditions prior to surgery according to the study protocol. Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of block application (procedure difficulty score)
The ease of application of the block will be evaluated using a 10-point numerical rating scale (0-10), where lower scores indicate easier application and higher scores indicate greater procedural difficulty. The score will be assigned by the anesthesiologist performing the block immediately after completion of the procedure.
Measured: Immediately after block performance
Secondary outcomes (2)
Postoperative pain score at 24 hours
Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (0 = no pain, 10 = worst imaginable pain) at 24 hours after surgery.
Measured: 24 hours postoperatively
Quality of recovery at 24 hours
Postoperative recovery quality will be assessed using the Quality of recovery (QoR-15) questionnaire at 24 hours after surgery. The total score ranges from 0 to 150, with higher scores indicating better recovery.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Jun 2026
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomly assigned to one of two parallel groups to receive either a serratus posterior superior intercostal plane (SPSIP) block or an erector spinae plane (ESP) block for postoperative analgesia following mastectomy. The study is designed as a parallel-group trial. Randomization will be performed using a computer-generated sequence. Blinding will be maintained such that the patient, the care providers responsible for perioperative management, and the outcome assessors are unaware of group allocation. Only the anesthesiologist performing the block will be aware of the assigned intervention and will not be involved in postoperative data collection or outcome assessment.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MEHMETGOKHAN, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561853
- Sponsor's protocol ID
- SAU-ANE-MGK-01
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Serratus Posterior Superior Intercostal Plane Block and Erector Spinae Plane Block in Breast Surgery in Terms of Ease of Application and Patient Comfort
- ClinicalTrials.gov ID
- NCT07561853
- Acronym / sponsor ID
- SAU-ANE-MGK-01
- Conditions
- Postoperative Pain
- Keywords
- Serratus Posterior Superior Intercostal Plane Block, Erector Spinae Plane Block, Mastectomy, Postoperative Pain, Fascial Plane Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 1 May 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 after mastectomy remains a significant clinical problem that may impair patient comfort and delay early rehabilitation, potentially affecting functional recovery. Various analgesic techniques are used to manage postoperative pain. This study aims to compare serratus posterior superior intercostal plane block and erector spinae plane block, which are routinely used in our clinic for postoperative analgesia in patients undergoing mastectomy, in terms of ease of application and patient comfort.
Detailed description
Postoperative pain following mastectomy is a common and clinically significant issue that not only reduces patient comfort but may also hinder early mobilization and rehabilitation, thereby negatively impacting overall functional outcomes. Effective postoperative analgesia is therefore a key component of perioperative care in breast surgery.
A variety of analgesic techniques, including systemic analgesics and regional anesthesia methods, are currently employed to manage postoperative pain. Among these, ultrasound-guided fascial plane blocks have gained increasing popularity due to their relative safety, simplicity, and effectiveness. The serratus posterior superior intercostal plane (SPSIP) block and the erector spinae plane (ESP) block are two such regional techniques used for thoracic analgesia.
In our clinical practice, both SPSIP and ESP blocks are routinely used for patients undergoing mastectomy. However, comparative data regarding their ease of application and impact on patient comfort are limited. Ease of application is an important consideration for anesthesiologists, particularly in busy clinical settings, while patient comfort during block placement is a critical but often underreported outcome.
The primary aim of this study is to compare SPSIP block and ESP block in patients undergoing mastectomy in terms of ease of application and patient comfort during the procedure. Secondary considerations may include block-related characteristics and their contribution to postoperative recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups to receive either a serratus posterior superior intercostal plane (SPSIP) block or an erector spinae plane (ESP) block for postoperative analgesia following mastectomy. The study is designed as a parallel-group trial. Randomization will be performed using a computer-generated sequence. Blinding will be maintained such that the patient, the care providers responsible for perioperative management, and the outcome assessors are unaware of group allocation. Only the anesthesiologist performing the block will be aware of the assigned intervention and will not be involved in postoperative data collection or outcome assessment.
| Arm | Type | Receives |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block Group | Experimental | Procedure: Serratus posterior superior intercostal plane blockParticipants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block for postoperative analgesia following mastectomy. The block will be performed under standardized conditions prior to surgery according to the study protocol. |
| Erector Spinae Plane Block Group | Experimental | Procedure: Erector Spinae Plane BlockParticipants in this group will receive an ultrasound-guided erector spinae plane (ESP) block for postoperative analgesia following mastectomy. The block will be performed under standardized conditions prior to surgery according to the study protocol. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female Gender
- Mastectomy operation
- 25-65 years
- American Society Anestheosiology Physical Status I-III
Key exclusion criteria (4 listed)
- American Society Anestheosiology Physical Status IV
- Alcohol or substance abuse
- Known allergy to local anesthetics or opioids
- Severe psychiatric disorders
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 |
|---|---|---|
| Serratus posterior superior intercostal plane blockParticipants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block for postoperative analgesia following mastectomy. The block will be performed under standardized conditions prior to surgery according to the study protocol. | Procedure or surgery | Serratus Posterior Superior Intercostal Plane Block Group |
| Erector Spinae Plane BlockParticipants in this group will receive an ultrasound-guided erector spinae plane (ESP) block for postoperative analgesia following mastectomy. The block will be performed under standardized conditions prior to surgery according to the study protocol. | Procedure or surgery | Erector Spinae Plane Block Group |
Primary outcome
Ease of block application (procedure difficulty score)
Time frame: Immediately after block performance
The ease of application of the block will be evaluated using a 10-point numerical rating scale (0-10), where lower scores indicate easier application and higher scores indicate greater procedural difficulty. The score will be assigned by the anesthesiologist performing the block immediately after completion of the procedure.
2 secondary outcomes
Postoperative pain score at 24 hours
Time frame: 24 hours postoperatively
Quality of recovery at 24 hours
Time frame: 24 hours postoperatively
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 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Sakarya University-Anesthesiology and Reanimation Department
Sakarya, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus posterior superior intercostal plane block and Erector Spinae Plane Block in people with Postoperative Pain, run by Sakarya 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 4 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 11 Sep 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?
Ease of block application (procedure difficulty score) (time frame: Immediately after block performance). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2026.