Erector Spinae Plane BlockNCT07134933
The Effects of Erector Spinae Plane Block on Pain Scores in Unilateral Breast Cancer Surgery
A study testing ESP (erector spinae plane)block in people with Erector Spinae Plane Block, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The high incidence of breast cancer is increasing the need for oncologic breast surgery. The optimal acute postoperative pain management after breast surgery is not yet clear. The erector spinae plane block (ESPB) is a newer and may be potentially safer alternative other regional analgesia techniques. 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
- What is being tested?
- ESP (erector spinae plane)block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2018to 20 Apr 2019
- 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
- ASA I-II
- the patients who undergone unilateral surgery due to breast tumors
Who cannot join
- obesity (body mass index> 35 kg/m²)
- infection at the needle entry site,
- known allergy history to the medications to be used,
- coagulopathy
- a history of opioid use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İnonu University Medicine Faculty Turgut ozal Medical Center
Malatya, 44100
About this study
Official title: The Effects of Erector Spinae Plane Block on Pain Scores and Patient Experience in Unilateral Breast Cancer Surgery: A Prospective, Randomized Clinical Trial
The high incidence of breast cancer is increasing the need for oncologic breast surgery. The optimal acute postoperative pain management after breast surgery is not yet clear. The erector spinae plane block (ESPB) is a newer and may be potentially safer alternative other regional analgesia techniques. We will investigate the effectiveness of ESP for managing acute pain after breast cancer surgery. Patients will randomise to receive either ESP block (Group1)or no ESP block (Group II). The primary outcome is postoperative pain scores used Visual Analog Scale (VAS), and the secondary outcomes include intraoperative opioid consumption postoperative total opioid consumption and patient satisfaction.
Read the detailed description
Anesthesia induction was achieved with propofol (2-3 mg kg-1), fentanyl (2 mcg kg-1), and rocuronium (0.6 mg kg-1). Anesthesia was maintained with Total intravenous anesthesia (TIVA) used remifentanil (0.25-0.5 mcg kg-1 min-1) and propofol (150 mcg kg-1 min-1). During maintenance, a fresh gas flow of 3 L with a mixture of 50% oxygen and 50% air was used. The BIS value was kept between 30-50.
Patients were divided into two groups according to a computer-based simple randomization method. Those who received a preoperative ESP block at the T4 vertebra level under ultrasound guidance were designated as Group I, while those who underwent surgery without the block were designated as Group II.
The ESP block was performed unilaterally in the direction of the surgery by the same anesthetist. Blocks were performed using an Esaote ultrasound device (Esaote My Lab 6 US machine, Florence, Italy), a multifrequency convex probe (1-8 MHz), and a 22-gauge, 50 mm facet needle (B. Braun Sonoplex, Melsungen, Germany) The block needle was placed at the level of the T4 spinal process using the in-plane approach, approximately 3 cm lateral to the T4 spinous process in the parasagittal plane. After visualizing the transverse process with the in-plane approach, the 50 mm facet needle (B. Braun Sonoplex, Melsungen, Germany) was inserted through the skin, and a test dose of 1 ml of 0.9% NaCl was injected between the fascia of the trapezius, rhomboid, and erector spinae muscles and the transverse vertebral process to confirm the location. A total of 20 ml of 0.5% bupivacaine was used as a local anesthetic. The cranial and caudal spread of the local anesthetic was monitored.
- Conditions
- Erector Spinae Plane Block
- Being tested
- ESP (erector spinae plane)block
- Keywords
- Erector spinae plane block, patient satisfaction, breast surgery, postoperative analgesia
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP (erector spinae plane)blockProcedure or surgery
The ESP block was performed unilaterally in the direction of the surgery by the same anesthetist. Blocks were performed using an Esaote ultrasound device (Esaote My Lab 6 US machine, Florence, Italy), a multifrequency convex probe (1-8 MHz), and a 22-gauge, 50 mm facet needle (B. Braun Sonoplex, Melsungen, Germany). The block needle was placed at the level of the T4 spinal process using the in-plane approach, approximately 3 cm lateral to the T4 spinous process in the parasagittal plane. After visualizing the transverse process with the in-plane approach, the 50 mm facet needle (B. Braun Sonoplex, Melsungen, Germany) was inserted through the skin, and a test dose of 1 ml of 0.9% NaCl was injected between the fascia of the trapezius, rhomboid, and erector spinae muscles and the transverse vertebral process to confirm the location. A total of 20 ml of 0.5% bupivacaine was used as a local anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | The group with ESP block was defined as Group 1. The ESP block was performed unilaterally in the direction of the surgery. Receives: Procedure: ESP (erector spinae plane)block |
| Group II | No intervention | The group without ESP block was defined as Group II. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remifentanil Consumption
The primary aim of our study was to compare perioperative remifentanil consumption between Group I patients who received a preoperative ESP block and Group II patients who underwent surgery without the block.
Measured: From beginning of anesthesia to finished the surgery
Secondary outcomes (3)
postoperative morphine consumption
After extubation, a patient-controlled analgesia device containing morphine (0.5 mg/ml, 1 mg bolus, 8-minute lockout interval, maximum dose of 6 mg in 1 hour) was installed. The amount of morphine consumed in the postoperative 24 hours was measured.
Measured: from the end of the surgery to 24 hours of postoperative
The VAS scores
Postoperative pain assessment was conducted using the Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates unbearable pain) at rest and during movement at the 5, 15, 30, and 60 minutes, as well as at 2, 4, 6, 8, 16, and 24 hours post-surgery.
Measured: from the end of the surgery to 24 hours of postoperative
patient satisfaction
a four-point patient satisfaction score (1: poor, 2: fair, 3: good, 4: excellent) were evaluated by an anesthetist who was unaware of the study groups.
Measured: at the 24th postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start25 Dec 2018
- Primary completion1 Mar 2019
- Study completion20 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erector Spinae Plane BlockStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mukadder Sanli, Inonu University
- Investigators
- Mukadder Sanli, Associate Professor, Study chair, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134933
- Sponsor's protocol ID
- ESP Block
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not want our data to be used by others.
Publications
Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.
PubMed 28564673
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Erector Spinae Plane Block on Pain Scores and Patient Experience in Unilateral Breast Cancer Surgery: A Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07134933
- Acronym / sponsor ID
- ESP Block
- Conditions
- Erector Spinae Plane Block
- Keywords
- Erector spinae plane block, patient satisfaction, breast surgery, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 25 Dec 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 20 Apr 2019 (actual)
- First posted
- 21 Aug 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 high incidence of breast cancer is increasing the need for oncologic breast surgery. The optimal acute postoperative pain management after breast surgery is not yet clear. The erector spinae plane block (ESPB) is a newer and may be potentially safer alternative other regional analgesia techniques. We will investigate the effectiveness of ESP for managing acute pain after breast cancer surgery. Patients will randomise to receive either ESP block (Group1)or no ESP block (Group II). The primary outcome is postoperative pain scores used Visual Analog Scale (VAS), and the secondary outcomes include intraoperative opioid consumption postoperative total opioid consumption and patient satisfaction.
Detailed description
Anesthesia induction was achieved with propofol (2-3 mg kg-1), fentanyl (2 mcg kg-1), and rocuronium (0.6 mg kg-1). Anesthesia was maintained with Total intravenous anesthesia (TIVA) used remifentanil (0.25-0.5 mcg kg-1 min-1) and propofol (150 mcg kg-1 min-1). During maintenance, a fresh gas flow of 3 L with a mixture of 50% oxygen and 50% air was used. The BIS value was kept between 30-50.
Patients were divided into two groups according to a computer-based simple randomization method. Those who received a preoperative ESP block at the T4 vertebra level under ultrasound guidance were designated as Group I, while those who underwent surgery without the block were designated as Group II.
The ESP block was performed unilaterally in the direction of the surgery by the same anesthetist. Blocks were performed using an Esaote ultrasound device (Esaote My Lab 6 US machine, Florence, Italy), a multifrequency convex probe (1-8 MHz), and a 22-gauge, 50 mm facet needle (B. Braun Sonoplex, Melsungen, Germany) The block needle was placed at the level of the T4 spinal process using the in-plane approach, approximately 3 cm lateral to the T4 spinous process in the parasagittal plane. After visualizing the transverse process with the in-plane approach, the 50 mm facet needle (B. Braun Sonoplex, Melsungen, Germany) was inserted through the skin, and a test dose of 1 ml of 0.9% NaCl was injected between the fascia of the trapezius, rhomboid, and erector spinae muscles and the transverse vertebral process to confirm the location. A total of 20 ml of 0.5% bupivacaine was used as a local anesthetic. The cranial and caudal spread of the local anesthetic was monitored.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: ESP (erector spinae plane)blockThe group with ESP block was defined as Group 1. The ESP block was performed unilaterally in the direction of the surgery. |
| Group II | No intervention | –The group without ESP block was defined as Group II. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II
- the patients who undergone unilateral surgery due to breast tumors
Key exclusion criteria (5 listed)
- obesity (body mass index> 35 kg/m²)
- infection at the needle entry site,
- known allergy history to the medications to be used,
- coagulopathy
- a history of opioid use
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 |
|---|---|---|
| ESP (erector spinae plane)blockThe ESP block was performed unilaterally in the direction of the surgery by the same anesthetist. Blocks were performed using an Esaote ultrasound device (Esaote My Lab 6 US machine, Florence, Italy), a multifrequency convex probe (1-8 MHz), and a 22-gauge, 50 mm facet needle (B. Braun Sonoplex, Melsungen, Germany). The block needle was placed at the level of the T4 spinal process using the in-plane approach, approximately 3 cm lateral to the T4 spinous process in the parasagittal plane. After visualizing the transverse process with the in-plane approach, the 50 mm facet needle (B. Braun Sonoplex, Melsungen, Germany) was inserted through the skin, and a test dose of 1 ml of 0.9% NaCl was injected between the fascia of the trapezius, rhomboid, and erector spinae muscles and the transverse vertebral process to confirm the location. A total of 20 ml of 0.5% bupivacaine was used as a local anesthetic. | Procedure or surgery | Group I |
Primary outcome
Remifentanil Consumption
Time frame: From beginning of anesthesia to finished the surgery
The primary aim of our study was to compare perioperative remifentanil consumption between Group I patients who received a preoperative ESP block and Group II patients who underwent surgery without the block.
3 secondary outcomes
postoperative morphine consumption
Time frame: from the end of the surgery to 24 hours of postoperative
The VAS scores
Time frame: from the end of the surgery to 24 hours of postoperative
patient satisfaction
Time frame: at the 24th postoperative 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 21 Aug 2025.
- Background: PubMed 28564673Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.
- Individual participant dataSharing planned: No. We do not want our data to be used by others.
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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.
Mukadder Sanli, Associate Professor study chair
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESP (erector spinae plane)block in people with Erector Spinae Plane Block, run by Inonu 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 2 inclusion and 5 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 21 Aug 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?
Remifentanil Consumption (time frame: From beginning of anesthesia to finished the 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 NCT07134933, which also lists 1 linked publication.
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 21 Aug 2025.