Erector Spinae Plane BlockNCT06407037
Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block
A study testing Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block in people with Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Breast cancer is the most common malignancy in women. Modified radical mastectomy, a surgical procedure in the treatment of breast cancer, is one of the standard treatments. Postoperative pain can seriously reduce the quality of life in patients, and inadequately treated acute pain can trigger chronic pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Erector Spinae Plane Block, Serratus Posterior Superior Intercostal Plane Block, Acute Pain
- What is being tested?
- Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block
- Type of treatment
- 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
- 27 Dec 2023to 17 Feb 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those aged 18-65
- Those with ASA scores I-II-III
- Those with a body mass index (BMI) between 18-35
- Patients who will undergo breast surgery
Who cannot join
- Those under the age of 18 and over the age of 65
- Those with ASA score IV and above
- Those with a history of allergy to the drugs to be blocked
- Those with a history of bleeding diathesis
- Patients with infection in the area to be blocked
- Those with a BMI below 18 and above 35
- Patients who underwent surgery under emergency conditions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Yenimahalle, Ankara, 06170
About this study
Official title: Comparison of the Effects of Ultrasound-Guided Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block on Postoperative Acute Pain in Patients Undergoing Breast Surgery
Breast cancer is the most common malignancy in women. Modified radical mastectomy, a surgical procedure in the treatment of breast cancer, is one of the standard treatments. Postoperative pain can seriously reduce the quality of life in patients, and inadequately treated acute pain can trigger chronic pain syndrome. Therefore, thoracic paravertebral block and thoracic epidural block are effective in postoperative analgesia. However, the use of these blocks is limited due to complications. In recent years, less invasive blocks, such as pectoral nerve block (PECS I-II), Serratus anterior plane block (SAPB), Erector spinae plane block (ESPB), and Serratus Posterior Superior intercostal Plane Block (SPSİPB) have been applied. In this study, it was aimed to compare the analgesic effectiveness of ESPB and SPSİPB applications in patients undergoing breast surgery.
Read the detailed description
Postoperative pain will be assessed during resting and coughing with a visual analog scale (0-10 cm) and nausea and vomiting with a Postoperative Nausea Vomiting Score at the postoperative 1, 4, 8, 12, and 24 hours. The amount of tramadol consumed in the postoperative period will be recorded. Patient satisfaction will be assessed with the Likert scale at postoperative 24 hours.
- Conditions
- Erector Spinae Plane Block, Serratus Posterior Superior Intercostal Plane Block, Acute Pain, Postoperative Pain, Breast Neoplasms
- Being tested
- Erector Spinae Plane Block, Serratus Posterior Superior Intercostal Plane Block
- Medical subject headings
- Acute Pain, Pain, Postoperative, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, when the patient is placed in the lateral decubitus position. 30 ml of 0.25% bupivacaine will be used in applications.
Serratus Posterior Superior Intercostal Plane BlockProcedure or surgery
Serratus Posterior Superior Intercostal Plane Block will be performed unilaterally, under US guidance, before the surgical operation, when the patient is placed in the lateral decubitus position. 30 ml of 0.25% bupivacaine will be used in applications.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 30 ml of 0.25% bupivacaine was injected into the area. Receives: Procedure: Erector Spinae Plane Block |
| Serratus Posterior Superior Intercostal Plane Block | Active comparator | The probe was placed on the spinae scapula in the sagittal plane to identify the second and third ribs. The trapezius, rhomboid, serratus posterior superior muscle were visualized. The needle was inserted just above the third rib deeply into the serratus posterior superior muscle. Two mL isotonic was administrated for the correction. Then, 30 mL of 0.25% bupivacaine was administrated between serratus posterior superior muscle and rib. Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia
Pain will be assessed with a visual analog scale (0-10 cm)
Measured: Postoperative day 1
Secondary outcomes (2)
Postoperative tramadol consumption
The amount of tramadol consumed in the postoperative period will be recorded
Measured: Perioperative day 1
Patient satisfaction
Satisfaction will be assessed with a 5 point Likert scale (0-4 whereas 0:definitely disagree; 1:slightly agree; 3: agree; 4: strongly agree)
Measured: Postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start27 Dec 2023
- Primary completion3 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae Plane BlockStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emine Arik, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407037
- Sponsor's protocol ID
- AEŞH-EK1-2023-824
- Status last verified
- Mar 2025
- First submitted
- 6 May 2024
- Last updated
- 13 Mar 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 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Ultrasound-Guided Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block on Postoperative Acute Pain in Patients Undergoing Breast Surgery
- ClinicalTrials.gov ID
- NCT06407037
- Acronym / sponsor ID
- AEŞH-EK1-2023-824
- Conditions
- Erector Spinae Plane Block, Serratus Posterior Superior Intercostal Plane Block, Acute Pain, Postoperative Pain, Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 9 May 2024 (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.
Breast cancer is the most common malignancy in women. Modified radical mastectomy, a surgical procedure in the treatment of breast cancer, is one of the standard treatments. Postoperative pain can seriously reduce the quality of life in patients, and inadequately treated acute pain can trigger chronic pain syndrome. Therefore, thoracic paravertebral block and thoracic epidural block are effective in postoperative analgesia. However, the use of these blocks is limited due to complications. In recent years, less invasive blocks, such as pectoral nerve block (PECS I-II), Serratus anterior plane block (SAPB), Erector spinae plane block (ESPB), and Serratus Posterior Superior intercostal Plane Block (SPSİPB) have been applied. In this study, it was aimed to compare the analgesic effectiveness of ESPB and SPSİPB applications in patients undergoing breast surgery.
Detailed description
Postoperative pain will be assessed during resting and coughing with a visual analog scale (0-10 cm) and nausea and vomiting with a Postoperative Nausea Vomiting Score at the postoperative 1, 4, 8, 12, and 24 hours. The amount of tramadol consumed in the postoperative period will be recorded. Patient satisfaction will be assessed with the Likert scale at postoperative 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Procedure: Erector Spinae Plane BlockFollowing the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 30 ml of 0.25% bupivacaine was injected into the area. |
| Serratus Posterior Superior Intercostal Plane Block | Active comparator | Procedure: Serratus Posterior Superior Intercostal Plane BlockThe probe was placed on the spinae scapula in the sagittal plane to identify the second and third ribs. The trapezius, rhomboid, serratus posterior superior muscle were visualized. The needle was inserted just above the third rib deeply into the serratus posterior superior muscle. Two mL isotonic was administrated for the correction. Then, 30 mL of 0.25% bupivacaine was administrated between serratus posterior superior muscle and 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)
- Those aged 18-65
- Those with ASA scores I-II-III
- Those with a body mass index (BMI) between 18-35
- Patients who will undergo breast surgery
Key exclusion criteria (7 listed)
- Those under the age of 18 and over the age of 65
- Those with ASA score IV and above
- Those with a history of allergy to the drugs to be blocked
- Those with a history of bleeding diathesis
- Patients with infection in the area to be blocked
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 Spinae Plane BlockErector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, when the patient is placed in the lateral decubitus position. 30 ml of 0.25% bupivacaine will be used in applications. | Procedure or surgery | Erector Spinae Plane Block |
| Serratus Posterior Superior Intercostal Plane BlockSerratus Posterior Superior Intercostal Plane Block will be performed unilaterally, under US guidance, before the surgical operation, when the patient is placed in the lateral decubitus position. 30 ml of 0.25% bupivacaine will be used in applications. | Procedure or surgery | Serratus Posterior Superior Intercostal Plane Block |
Primary outcome
Postoperative analgesia
Time frame: Postoperative day 1
Pain will be assessed with a visual analog scale (0-10 cm)
2 secondary outcomes
Postoperative tramadol consumption
Time frame: Perioperative day 1
Patient satisfaction
Time frame: Postoperative 24th hour
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 13 Mar 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 Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block in people with Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block, run by Diskapi Yildirim Beyazit Education 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 13 Mar 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?
Postoperative analgesia (time frame: Postoperative day 1). 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 13 Mar 2025.