Post Operative PainNCT06862752
Erector Spinae Plane Block Versus Serratus Anterior Plane Block
A study testing erector spine plane (ESP) block and Serratus Anterior Plane Block in people with Post Operative Pain and Opioid-Related Disorders, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
the aim of the study compare the analgesic effect of erector spinae block and serratus anterior block in breast surgery Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Post Operative Pain, Opioid-Related Disorders
- What is being tested?
- erector spine plane (ESP) block and Serratus Anterior Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 15 Jan 2026
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) I-II,
- 18-65 years of age, adult,
- female patients
- undergoing elective breast reduction surgery
Who cannot join
- Allergy to amide-type local anesthetics
- Infection at the block injection site
- Severe obesity (BMI > 35 kg/m2)
- Liver or renal deficiency
- Patients with anatomical deformities
- Recent use of analgesic drugs
- Patient refusal or inability to consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli etfal research and training hospital
Istanbul, 34371
About this study
Official title: Bilateral Ultrasound-Guided Erector Spinae Plane Block or Serratus Anterior Plane Block For Postoperative Analgesia in Breast Reduction Surgery: A Prospective, Randomized and Controlled Trial
the aim of the study compare the analgesic effect of erector spinae block and serratus anterior block in breast surgery
Read the detailed description
Breast reduction surgery is a common cosmetic surgical procedure. Providing effective analgesia has a crucial role in reducing side effects, catalyzing postoperative recovery, and increasing patient satisfaction. Regional anesthesia techniques are generally used for postoperative analgesia to decrease opioid-related side effects. Fascial plane block has gained popularity for breast analgesia. The investigator aimed to consider the effects of ESP block or Serratus Anterior Plane block on postoperative analgesia in breast reduction surgery.
- Conditions
- Post Operative Pain, Opioid-Related Disorders
- Being tested
- erector spine plane (ESP) block, Serratus Anterior Plane Block
- Keywords
- post operative pain, opioid consumption, erector spinae block, serratus anterior plane block
- Medical subject headings
- Pain, Postoperative, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spine plane (ESP) blockProcedure or surgery
Bilateral ultrasound guided erector spine plane (ESP) block will be performe preoperatively at T5 level. 20 mL local anesthetics (10 mL 0.5% bupivacaine + 10 mL serum physiologic % l) will be injected deep to the erector spinae muscle.
Serratus Anterior Plane BlockProcedure or surgery
Bilateral ultrasound guided serratus plane block with 20 ml %0,25 bupivacaine at the midaxillary 5. Rib
| Study group | Role | What they receive |
|---|---|---|
| ESP block group | Active comparator | Bilateral ultrasound guided erector spine plane (ESP) block will be performe preoperatively at T5 level. 20 mL local anesthetics (10 mL 0.5% bupivacaine + 10 mL serum physiologic % l) will be injected deep to the erector spinae muscle Receives: Procedure: erector spine plane (ESP) block |
| SAP Block grup | Other | Bilateral ultrasound guided serratus plane block with 20 ml %0,25 bupivacaine at the midaxillary 5. Rib Receives: Procedure: Serratus Anterior Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Tramadol consumption in Patient Controlled Analgesia device postoperative 24 hours.
Measured: 24 hour
Secondary outcomes (5)
Pain assessed by NRS
Post operative pain will be evaluated with Numeric rating scale (NRS) score of 0-10 (0= no pain and 10= pain) and will be recorded at 0,1,4,12,24. At hours postoperatively.
Measured: 24 hour
Rate of opioid related side effects
Opioid related side effects such as nause/vomiting, pruritis, bradycardia, hypotension will be evaluated at intervals up to 24 hours.
Measured: 24 hour
Blooad loss
Peroperative and postoperative blood loss and amaoun of eritrosit suspansion
Measured: during surgery
Remifentanil consumption
Peroperative Remifentanil consumption
Measured: during surgery
Length of stay in hospital
Length of stay in hospital
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Apr 2025
- Primary completion1 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Kılınc, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- AYSE SURHAN CINAR, Study chair, SISLI HAMIDIYE ETFAL RESEARCH AND TRAINING
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862752
- Sponsor's protocol ID
- leyla-25
- Status last verified
- Aug 2026
- First submitted
- 1 Mar 2025
- Last updated
- 20 Aug 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Ultrasound-Guided Erector Spinae Plane Block or Serratus Anterior Plane Block For Postoperative Analgesia in Breast Reduction Surgery: A Prospective, Randomized and Controlled Trial
- ClinicalTrials.gov ID
- NCT06862752
- Acronym / sponsor ID
- leyla-25
- Conditions
- Post Operative Pain, Opioid-Related Disorders
- Keywords
- post operative pain, opioid consumption, erector spinae block, serratus anterior plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 6 Mar 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 the study compare the analgesic effect of erector spinae block and serratus anterior block in breast surgery
Detailed description
Breast reduction surgery is a common cosmetic surgical procedure. Providing effective analgesia has a crucial role in reducing side effects, catalyzing postoperative recovery, and increasing patient satisfaction. Regional anesthesia techniques are generally used for postoperative analgesia to decrease opioid-related side effects. Fascial plane block has gained popularity for breast analgesia. The investigator aimed to consider the effects of ESP block or Serratus Anterior Plane block on postoperative analgesia in breast reduction surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP block group | Active comparator | Procedure: erector spine plane (ESP) blockBilateral ultrasound guided erector spine plane (ESP) block will be performe preoperatively at T5 level. 20 mL local anesthetics (10 mL 0.5% bupivacaine + 10 mL serum physiologic % l) will be injected deep to the erector spinae muscle |
| SAP Block grup | Other | Procedure: Serratus Anterior Plane BlockBilateral ultrasound guided serratus plane block with 20 ml %0,25 bupivacaine at the midaxillary 5. Rib |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) I-II,
- 18-65 years of age, adult,
- female patients
- undergoing elective breast reduction surgery
Key exclusion criteria (7 listed)
- Allergy to amide-type local anesthetics
- Infection at the block injection site
- Severe obesity (BMI > 35 kg/m2)
- Liver or renal deficiency
- Patients with anatomical deformities
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 |
|---|---|---|
| erector spine plane (ESP) blockBilateral ultrasound guided erector spine plane (ESP) block will be performe preoperatively at T5 level. 20 mL local anesthetics (10 mL 0.5% bupivacaine + 10 mL serum physiologic % l) will be injected deep to the erector spinae muscle. | Procedure or surgery | ESP block group |
| Serratus Anterior Plane BlockBilateral ultrasound guided serratus plane block with 20 ml %0,25 bupivacaine at the midaxillary 5. Rib | Procedure or surgery | SAP Block grup |
Primary outcome
Opioid consumption
Time frame: 24 hour
Tramadol consumption in Patient Controlled Analgesia device postoperative 24 hours.
5 secondary outcomes
Pain assessed by NRS
Time frame: 24 hour
Rate of opioid related side effects
Time frame: 24 hour
Blooad loss
Time frame: during surgery
Remifentanil consumption
Time frame: during surgery
Length of stay in hospital
Time frame: 30 days
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 20 Aug 2026.
- 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.
AYSE SURHAN CINAR study chair
SISLI HAMIDIYE ETFAL RESEARCH AND TRAINING
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erector spine plane (ESP) block and Serratus Anterior Plane Block in people with Post Operative Pain and Opioid-Related Disorders, run by Sisli Hamidiye Etfal Training and Research 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 7 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 20 Aug 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?
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?
Opioid consumption (time frame: 24 hour). 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 20 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.