Breast SurgeryNCT06611644
Comparison of ESP and SPSIP Blocks in Breast Surgery
A study testing Erector Spinae Plane Block and SPSIPB blcok in people with Breast Surgery and Macromastia, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the efficacy of the ESP and SPSIP blocks in managing postoperative pain following breast surgery. Breast surgery, particularly after oncological and reconstructive procedures, often leads to significant postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Surgery, Macromastia, Mammaplasty
- What is being tested?
- Erector Spinae Plane Block and SPSIPB blcok
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jul 2024to 16 Jan 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
- Age between 18 and 65 years.
- Scheduled for breast surgery (Modified Radical Mastectomy with or without axillary lymph node dissection, Mastopexy, Reduction Mammoplasty).
- Preoperative anesthesia risk classified as ASA I-III according to the American -Society of Anesthesiologists (ASA) classification.
- Patients who provide informed consent for participation in the study.
Who cannot join
- History of coagulation disorders.
- Patients using aspirin or medically prescribed anticoagulants.
- Patients with severe systemic diseases (ASA IV).
- Patients undergoing emergency surgery.
- Patients younger than 18 or older than 65 years.
- Patients who do not develop adequate sensory block after the procedure.
Show all 9Show fewer
- Presence of infection at the block site.
- Patients with thoracic deformities.
- Patients who decline to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Canakkale Onsekiz Mart University
Çanakkale, 17020
About this study
Official title: A Comparative Analysis of Erector Spinae Plane (ESP) Block and Serratus Posterior Superior Intercostal Plane (SPSIP) Block in Breast Surgery
This study aims to compare the efficacy of the ESP and SPSIP blocks in managing postoperative pain following breast surgery. Breast surgery, particularly after oncological and reconstructive procedures, often leads to significant postoperative pain. Effective pain control is crucial for accelerating recovery, reducing the risk of complications, and facilitating early discharge. Both ESP and SPSIP blocks involve the administration of local anesthetics into fascial plane spaces to achieve peripheral nerve blockade and control pain. This study will evaluate the effectiveness of these blocks in terms of pain scores, opioid consumption, and overall patient satisfaction to determine the optimal approach for postoperative pain management in breast surgery.
Read the detailed description
Breast surgery is one of the most frequently performed procedures, and effective postoperative pain management is critical to its success. Proper pain control not only facilitates early mobilization but also reduces the risks of pulmonary complications, deep vein thrombosis, and embolism. It helps prevent stress-induced endocrine and metabolic responses, shortens hospital stays, and lowers healthcare costs. Regional anesthesia is a highly effective strategy for postoperative pain control, minimizing opioid use and its associated side effects such as sedation, nausea, vomiting, and constipation.
Among the commonly used regional anesthesia techniques in breast surgery are the Erector Spinae Plane (ESP) block, Serratus Anterior Plane block, and Pectoral block. While the ESP block appears more effective, conflicting evidence exists regarding its efficacy in postoperative pain management, with variability in block spread across individuals. The recently introduced Serratus Posterior Superior Intercostal Plane (SPSIP) block, a periparavertebral block, offers a wider distribution range from C3 to T7 dermatomes, suggesting potential for more comprehensive postoperative analgesia in breast procedures.
The ESP block is performed under ultrasound guidance, using an in-plane technique to advance the needle from caudal to cranial (or vice versa), targeting the lateral part of the T6 transverse process, where local anesthetic is injected between the erector spinae muscle and the transverse process. For the SPSIP block, the needle is advanced between the second and third ribs towards the medial scapula, reaching the fascial plane between the serratus posterior superior muscle and the intercostal muscles. After hydrodissection confirms placement, local anesthetic is injected.
This study aims to compare the efficacy of ESP and SPSIP blocks in managing postoperative pain in breast surgery by evaluating pain scores, opioid consumption, and patient satisfaction. Since no study has yet directly compared these blocks, the findings will make a significant contribution to the existing literature.
- Conditions
- Breast Surgery, Macromastia, Mammaplasty, Modified Radical Mastectomy, Mammary Cancer, Breast Implant
- Being tested
- Erector Spinae Plane Block, SPSIPB blcok, Control
- Keywords
- Pain Management, Regional Anesthesia, Multimodal Treatment, Modified Radical Mastectomy, Mammaplasty, Breast Implants
- Medical subject headings
- Gigantomastia, Breast Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockOther
Patients in this group will receive an Erector Spinae Plane (ESP) block in addition to standard postoperative care. The ESP block will be performed under ultrasound guidance. A needle will be advanced in-plane or out-of-plane, targeting the lateral aspect of the T6 transverse process. Local anesthetic (20 to 30 ml) will be injected into the fascial plane between the erector spinae muscle and the transverse process. This block is intended to provide postoperative analgesia by blocking the transmission of pain through the thoracic spinal nerves.
SPSIPB blcokOther
Patients in this group will receive a Serratus Posterior Superior Intercostal Plane (SPSIP) block along with standard postoperative care. The SPSIP block will be performed under ultrasound guidance, where the needle is advanced between the second and third ribs towards the medial aspect of the scapula. Local anesthetic 20 to 30 ml) will be injected into the fascial plane between the serratus posterior superior muscle and the intercostal muscles after confirming needle placement with hydrodissection using 1-2 ml of saline. This block is intended to provide broad analgesia across the upper thoracic dermatomes, from C3 to T7, to control postoperative pain.
ControlOther
Patients in the control group will receive standard postoperative pain management without any regional block intervention. This will include the administration of systemic analgesics such as paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs). Opioid analgesics will be administered as needed based on the patient's pain level. Pain management will be conducted according to the standard protocol followed for breast surgery patients.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane (ESP) block group | Active comparator | This group will include patients who undergo the Erector Spinae Plane (ESP) block. The ESP block will be performed under ultrasound guidance, with a needle placed on the transverse process of the vertebra to inject local anesthetic into the erector spinae muscle. Receives: Other: Erector Spinae Plane Block |
| Serratus Posterior Superior Intercostal Plane (SPSIP) block | Active comparator | This group will include patients who undergo the Serratus Posterior Superior Intercostal Plane (SPSIP) block. The SPSIP block will be performed under ultrasound guidance, injecting local anesthetic into the plane between the serratus posterior superior muscle and the intercostal muscles. Receives: Other: SPSIPB blcok |
| Control Group | Other | Patients in this group will receive standard postoperative pain management. This management will be provided through systemic analgesics (e.g., paracetamol, nonsteroidal anti-inflammatory drugs, and opioids if necessary) based on the patient's pain level during the postoperative period. This group will consist of patients who do not receive regional blocks, and pain management will be conducted according to the standard procedure of the surgery. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Opioid Consumption
Postoperative opioid consumption will be monitored using a Patient-Controlled Analgesia (PCA) device, which will be connected to each patient at the end of surgery. The PCA settings will be 2 mg/cc tramadol solution, with no basal infusion, a lockout time of 20 minutes, and a 10 mg bolus dose. The total opioid (tramadol, Unit: miligram) consumption over 24 hours will be recorded, including the number of times the patient required analgesia and the number of bolus doses administered by the device.
Measured: 24 hours
Numeric Rating Scale (NRS)
Pain intensity will be assessed using the Numeric Rating Scale (NRS), where patients rate their pain on a scale from 0 (no pain) to 10 (worst possible pain). NRS scores will be recorded to evaluate postoperative pain levels in each group at specific intervals.
Measured: 24 hours postoperatively (measured at 0, 2, 6, 12, and 24 hours)
Secondary outcomes (3)
Verbal Descriptive Nausea and Vomiting Scale
Postoperative nausea and vomiting will be recorded for each patient at 0, 2, 6, 12, and 24 hours after surgery. The presence and severity of nausea and vomiting will be assessed using the Verbal Descriptive Nausea and Vomiting Scale, where 0 = none, 1 = mild nausea, 2 = moderate nausea, 3 = vomiting once, and 4 = vomiting more than once. This outcome will allow for a comparison of the potential of each technique to trigger postoperative nausea and vomiting.
Measured: 24 hours postoperatively (measured at 0, 2, 6, 12, and 24 hours)
Patient Satisfaction
Postoperative patient satisfaction will be measured to assess the overall acceptance and comfort related to the pain management strategies. Patient satisfaction will be rated on a three-point scale: good, moderate, or poor. This outcome will reflect the effectiveness of the pain management techniques in terms of patient comfort and overall experience.
Measured: 24 hours postoperatively
Length of Hospital Stay
The length of hospital stay (measured in hours) will be recorded for each patient to evaluate the potential for early discharge. A shorter hospital stay is typically associated with better pain management and faster recovery. This outcome will help assess the effectiveness of the pain control strategies in facilitating quicker recovery and discharge.
Measured: Up to 1 week postoperatively (measured in hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start6 Jul 2024
- Primary completion6 Jan 2025
- Study completion16 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study consists of three groups: a Control Group receiving standard postoperative pain management, an ESP Block Group receiving an Erector Spinae Plane (ESP) block, and an SPSIP Block Group receiving a Serratus Posterior Superior Intercostal Plane (SPSIP) block, all aimed at comparing the efficacy of these methods in managing postoperative pain.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mihrican SAYAN, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611644
- Sponsor's protocol ID
- COMU-SBF-ME-02
- Status last verified
- Feb 2025
- First submitted
- 22 Sep 2024
- Last updated
- 6 Feb 2025
- 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 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis of Erector Spinae Plane (ESP) Block and Serratus Posterior Superior Intercostal Plane (SPSIP) Block in Breast Surgery
- ClinicalTrials.gov ID
- NCT06611644
- Acronym / sponsor ID
- COMU-SBF-ME-02
- Conditions
- Breast Surgery, Macromastia, Mammaplasty, Modified Radical Mastectomy, Mammary Cancer, Breast Implant
- Keywords
- Pain Management, Regional Anesthesia, Multimodal Treatment, Modified Radical Mastectomy, Mammaplasty, Breast Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 6 Jul 2024 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 16 Jan 2025 (actual)
- First posted
- 25 Sep 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.
This study aims to compare the efficacy of the ESP and SPSIP blocks in managing postoperative pain following breast surgery. Breast surgery, particularly after oncological and reconstructive procedures, often leads to significant postoperative pain. Effective pain control is crucial for accelerating recovery, reducing the risk of complications, and facilitating early discharge. Both ESP and SPSIP blocks involve the administration of local anesthetics into fascial plane spaces to achieve peripheral nerve blockade and control pain. This study will evaluate the effectiveness of these blocks in terms of pain scores, opioid consumption, and overall patient satisfaction to determine the optimal approach for postoperative pain management in breast surgery.
Detailed description
Breast surgery is one of the most frequently performed procedures, and effective postoperative pain management is critical to its success. Proper pain control not only facilitates early mobilization but also reduces the risks of pulmonary complications, deep vein thrombosis, and embolism. It helps prevent stress-induced endocrine and metabolic responses, shortens hospital stays, and lowers healthcare costs. Regional anesthesia is a highly effective strategy for postoperative pain control, minimizing opioid use and its associated side effects such as sedation, nausea, vomiting, and constipation.
Among the commonly used regional anesthesia techniques in breast surgery are the Erector Spinae Plane (ESP) block, Serratus Anterior Plane block, and Pectoral block. While the ESP block appears more effective, conflicting evidence exists regarding its efficacy in postoperative pain management, with variability in block spread across individuals. The recently introduced Serratus Posterior Superior Intercostal Plane (SPSIP) block, a periparavertebral block, offers a wider distribution range from C3 to T7 dermatomes, suggesting potential for more comprehensive postoperative analgesia in breast procedures.
The ESP block is performed under ultrasound guidance, using an in-plane technique to advance the needle from caudal to cranial (or vice versa), targeting the lateral part of the T6 transverse process, where local anesthetic is injected between the erector spinae muscle and the transverse process. For the SPSIP block, the needle is advanced between the second and third ribs towards the medial scapula, reaching the fascial plane between the serratus posterior superior muscle and the intercostal muscles. After hydrodissection confirms placement, local anesthetic is injected.
This study aims to compare the efficacy of ESP and SPSIP blocks in managing postoperative pain in breast surgery by evaluating pain scores, opioid consumption, and patient satisfaction. Since no study has yet directly compared these blocks, the findings will make a significant contribution to the existing literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This study consists of three groups: a Control Group receiving standard postoperative pain management, an ESP Block Group receiving an Erector Spinae Plane (ESP) block, and an SPSIP Block Group receiving a Serratus Posterior Superior Intercostal Plane (SPSIP) block, all aimed at comparing the efficacy of these methods in managing postoperative pain.
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane (ESP) block group | Active comparator | Other: Erector Spinae Plane BlockThis group will include patients who undergo the Erector Spinae Plane (ESP) block. The ESP block will be performed under ultrasound guidance, with a needle placed on the transverse process of the vertebra to inject local anesthetic into the erector spinae muscle. |
| Serratus Posterior Superior Intercostal Plane (SPSIP) block | Active comparator | Other: SPSIPB blcokThis group will include patients who undergo the Serratus Posterior Superior Intercostal Plane (SPSIP) block. The SPSIP block will be performed under ultrasound guidance, injecting local anesthetic into the plane between the serratus posterior superior muscle and the intercostal muscles. |
| Control Group | Other | Other: ControlPatients in this group will receive standard postoperative pain management. This management will be provided through systemic analgesics (e.g., paracetamol, nonsteroidal anti-inflammatory drugs, and opioids if necessary) based on the patient's pain level during the postoperative period. This group will consist of patients who do not receive regional blocks, and pain management will be conducted according to the standard procedure of the surgery. |
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)
- Age between 18 and 65 years.
- Scheduled for breast surgery (Modified Radical Mastectomy with or without axillary lymph node dissection, Mastopexy, Reduction Mammoplasty).
- Preoperative anesthesia risk classified as ASA I-III according to the American -Society of Anesthesiologists (ASA) classification.
- Patients who provide informed consent for participation in the study.
Key exclusion criteria (9 listed)
- History of coagulation disorders.
- Patients using aspirin or medically prescribed anticoagulants.
- Patients with severe systemic diseases (ASA IV).
- Patients undergoing emergency surgery.
- Patients younger than 18 or older than 65 years.
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 BlockPatients in this group will receive an Erector Spinae Plane (ESP) block in addition to standard postoperative care. The ESP block will be performed under ultrasound guidance. A needle will be advanced in-plane or out-of-plane, targeting the lateral aspect of the T6 transverse process. Local anesthetic (20 to 30 ml) will be injected into the fascial plane between the erector spinae muscle and the transverse process. This block is intended to provide postoperative analgesia by blocking the transmission of pain through the thoracic spinal nerves. | Other | Erector Spinae Plane (ESP) block group |
| SPSIPB blcokPatients in this group will receive a Serratus Posterior Superior Intercostal Plane (SPSIP) block along with standard postoperative care. The SPSIP block will be performed under ultrasound guidance, where the needle is advanced between the second and third ribs towards the medial aspect of the scapula. Local anesthetic 20 to 30 ml) will be injected into the fascial plane between the serratus posterior superior muscle and the intercostal muscles after confirming needle placement with hydrodissection using 1-2 ml of saline. This block is intended to provide broad analgesia across the upper thoracic dermatomes, from C3 to T7, to control postoperative pain. | Other | Serratus Posterior Superior Intercostal Plane (SPSIP) block |
| ControlPatients in the control group will receive standard postoperative pain management without any regional block intervention. This will include the administration of systemic analgesics such as paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs). Opioid analgesics will be administered as needed based on the patient's pain level. Pain management will be conducted according to the standard protocol followed for breast surgery patients. | Other | Control Group |
Primary outcome
Postoperative Opioid Consumption
Time frame: 24 hours
Postoperative opioid consumption will be monitored using a Patient-Controlled Analgesia (PCA) device, which will be connected to each patient at the end of surgery. The PCA settings will be 2 mg/cc tramadol solution, with no basal infusion, a lockout time of 20 minutes, and a 10 mg bolus dose. The total opioid (tramadol, Unit: miligram) consumption over 24 hours will be recorded, including the number of times the patient required analgesia and the number of bolus doses administered by the device.
Numeric Rating Scale (NRS)
Time frame: 24 hours postoperatively (measured at 0, 2, 6, 12, and 24 hours)
Pain intensity will be assessed using the Numeric Rating Scale (NRS), where patients rate their pain on a scale from 0 (no pain) to 10 (worst possible pain). NRS scores will be recorded to evaluate postoperative pain levels in each group at specific intervals.
3 secondary outcomes
Verbal Descriptive Nausea and Vomiting Scale
Time frame: 24 hours postoperatively (measured at 0, 2, 6, 12, and 24 hours)
Patient Satisfaction
Time frame: 24 hours postoperatively
Length of Hospital Stay
Time frame: Up to 1 week postoperatively (measured in hours)
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 6 Feb 2025.
- 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.
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 SPSIPB blcok in people with Breast Surgery and Macromastia, run by Çanakkale Onsekiz Mart 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 9 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 6 Feb 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 Opioid Consumption (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 6 Feb 2025.