Pain Management After SurgeryDSAPBNCT07053397
We Have Two Groups. Both Groups Received a Deep Serratus Anterior Plane Block. One Group Had a Catheter for Continuous Infusion, While the Other Received IV Analgesics Postoperatively. Analgesic Effects Between the Two Groups Were Compared
A study testing Serratus Anterior Plane Block (SAPB) group and DSAPB in people with Pain Management After Surgery and Regional Anaesthesia, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study is to compare the analgesic efficacy of continuous infusion via peripheral catheter versus single-shot serratus anterior plane block in women aged 18 to 80 undergoing breast-conserving surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pain Management After Surgery, Regional Anaesthesia
- What is being tested?
- Serratus Anterior Plane Block (SAPB) group and DSAPB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jan 2025to 26 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 to 80 years
- Scheduled for breast-conserving surgery
- Classified as American Society of Anesthesiologists (ASA) physical status I, II, or III
Who cannot join
- Patients with coagulopathy
- Patients with wounds or infections at the block site
- Patients with known allergy to local anesthetic agents
- Patients with mental retardation or limited cooperation
- Patients who do not consent to participate in the study
- Patients who, for any reason, discontinue participation during the course of the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi
Istanbul, Kadıköy, 34722
About this study
Official title: A Comparative Study on the Analgesic Efficacy of Ultrasound-Guided Continuous Catheter-Based Deep Serratus Anterior Plane Block Versus Single-Injection Deep Serratus Anterior Plane Block in Patients Undergoing Breast Surgery
The aim of this observational study is to compare the analgesic efficacy of continuous infusion via peripheral catheter versus single-shot serratus anterior plane block in women aged 18 to 80 undergoing breast-conserving surgery. The main questions it aims to answer are: Does continuous serratus anterior plane block via peripheral catheter provide superior postoperative analgesic efficacy compared to single-shot serratus anterior plane block? Second question is: Does continuous infusion via catheter in peripheral nerve blocks reduce the amount of intravenous analgesics consumed and improve patient comfort?
- Being tested
- Serratus Anterior Plane Block (SAPB) group, DSAPB
- Keywords
- SAP, Deep SAP Block, Regional block, Peripheral block, Peripheral block cathather, continuous infusion via peripheral block cathather
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Anterior Plane Block (SAPB) groupProcedure or surgery
Also called serratus anterior plane block
The SAP block, which is among the chest wall blocks, provides its effect by blocking the lateral cutaneous branches of the T2-T9 intercostal nerves, n. intercostobrachial , n. longus thoracicus , n. thoracodorsal.
SAP block can be performed in two ways: superficial and deep. The deep SAP block is administered between the serratus anterior and intercostal muscles, at the intersection point of the anterior axillary line and the level of the nipple (at the level of the 4th-5th ribs).
It has a wide range of use for postoperative pain management in trauma surgery, cardiac surgery, thoracic surgery and breast surgery.
DSAPBProcedure or surgery
Also called serratus anterior plane peripheral block cathather replacement
The SAP block, which is among the chest wall blocks, provides its effect by blocking the lateral cutaneous branches of the T2-T9 intercostal nerves, n. intercostobrachial , n. longus thoracicus , n. thoracodorsal.
SAP block can be performed in two ways: superficial and deep. The deep SAP block is administered between the serratus anterior and intercostal muscles, at the intersection point of the anterior axillary line and the level of the nipple (at the level of the 4th-5th ribs). Following hydrodissection between the serratus anterior and intercostal muscles, a single-shot injection is administered. Subsequently, a peripheral nerve block catheter is placed in the same region under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| SAPB | Active comparator | The SAPB arm receives single shot deep serratus anterior plane block before surgery. Also receives iv analgesic treatment after post-operative duration. Receives: Procedure: Serratus Anterior Plane Block (SAPB) group |
| DSAPB | Experimental | The DSAPB arm receives deep serratus anterior plane block and cathather replacement before surgery. After surgery, the arm takes continous analgesic treatment via periferic block cathather. Receives: Procedure: Serratus Anterior Plane Block (SAPB) group; Procedure: DSAPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
1 - 10
1 is minimum pain 10 is maximum pain the lower scale is better for pain management.
Measured: Until discharge after surgery, during an average hospital stay of approximately 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start26 Jan 2025
- Primary completion26 Apr 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Management After SurgeryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Ağbulak, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053397
- Sponsor's protocol ID
- SAP001
- Acronym
- DSAPB
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on the Analgesic Efficacy of Ultrasound-Guided Continuous Catheter-Based Deep Serratus Anterior Plane Block Versus Single-Injection Deep Serratus Anterior Plane Block in Patients Undergoing Breast Surgery
- ClinicalTrials.gov ID
- NCT07053397
- Acronym / sponsor ID
- DSAPB / SAP001
- Keywords
- SAP, Deep SAP Block, Regional block, Peripheral block, Peripheral block cathather, continuous infusion via peripheral block cathather
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 26 Jan 2025 (actual)
- Primary completion
- 26 Apr 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 8 Jul 2025 (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 aim of this observational study is to compare the analgesic efficacy of continuous infusion via peripheral catheter versus single-shot serratus anterior plane block in women aged 18 to 80 undergoing breast-conserving surgery. The main questions it aims to answer are: Does continuous serratus anterior plane block via peripheral catheter provide superior postoperative analgesic efficacy compared to single-shot serratus anterior plane block? Second question is: Does continuous infusion via catheter in peripheral nerve blocks reduce the amount of intravenous analgesics consumed and improve patient comfort?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAPB | Active comparator | Procedure: Serratus Anterior Plane Block (SAPB) groupThe SAPB arm receives single shot deep serratus anterior plane block before surgery. Also receives iv analgesic treatment after post-operative duration. |
| DSAPB | Experimental | Procedure: Serratus Anterior Plane Block (SAPB) group, Procedure: DSAPBThe DSAPB arm receives deep serratus anterior plane block and cathather replacement before surgery. After surgery, the arm takes continous analgesic treatment via periferic block cathather. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients aged 18 to 80 years
- Scheduled for breast-conserving surgery
- Classified as American Society of Anesthesiologists (ASA) physical status I, II, or III
Key exclusion criteria (6 listed)
- Patients with coagulopathy
- Patients with wounds or infections at the block site
- Patients with known allergy to local anesthetic agents
- Patients with mental retardation or limited cooperation
- Patients who do not consent to participate in the study
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 Anterior Plane Block (SAPB) groupAlso: serratus anterior plane blockThe SAP block, which is among the chest wall blocks, provides its effect by blocking the lateral cutaneous branches of the T2-T9 intercostal nerves, n. intercostobrachial , n. longus thoracicus , n. thoracodorsal. SAP block can be performed in two ways: superficial and deep. The deep SAP block is administered between the serratus anterior and intercostal muscles, at the intersection point of the anterior axillary line and the level of the nipple (at the level of the 4th-5th ribs). It has a wide range of use for postoperative pain management in trauma surgery, cardiac surgery, thoracic surgery and breast surgery. | Procedure or surgery | DSAPB, SAPB |
| DSAPBAlso: serratus anterior plane peripheral block cathather replacementThe SAP block, which is among the chest wall blocks, provides its effect by blocking the lateral cutaneous branches of the T2-T9 intercostal nerves, n. intercostobrachial , n. longus thoracicus , n. thoracodorsal. SAP block can be performed in two ways: superficial and deep. The deep SAP block is administered between the serratus anterior and intercostal muscles, at the intersection point of the anterior axillary line and the level of the nipple (at the level of the 4th-5th ribs). Following hydrodissection between the serratus anterior and intercostal muscles, a single-shot injection is administered. Subsequently, a peripheral nerve block catheter is placed in the same region under ultrasound guidance. | Procedure or surgery | DSAPB |
Primary outcome
Numeric Rating Scale
Time frame: Until discharge after surgery, during an average hospital stay of approximately 24 hours.
1 - 10 1 is minimum pain 10 is maximum pain the lower scale is better for pain management.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
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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 Serratus Anterior Plane Block (SAPB) group and DSAPB in people with Pain Management After Surgery and Regional Anaesthesia, run by Istanbul Medeniyet 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 10 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numeric Rating Scale (time frame: Until discharge after surgery, during an average hospital stay of approximately 24 hours.). 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 10 Jul 2025.