AnalgesiaNCT06436599
SPSIPB Versus Deep SAPB for Analgesia After Breast Surgery
A study testing plane block with %0.25 30 ml bupivacaine in people with Analgesia, run by Mustafa Burgac at 1 site in Turkey (Türkiye).
Trial summary
The application of regional anaesthetic procedures in breast surgery is associated with a lower incidence of chronic pain, reduced morbidity, shorter hospital stay and less opioid requirement. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- plane block with %0.25 30 ml bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Dec 2023to 30 Jun 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- unilateral breast surgery
- ASA I-III risk group
Who cannot join
- Coagulopathy
- Wound and infection in the block area
- Local anaesthetic allergy
- Mental retardation
- Non-cooperative
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Professor Doctor Süleyman Yalçın City Hospital
Istanbul
About this study
Official title: Comparison of Serratus Posterior Superior Intercostal Plane Block Versus Deep Serratus Anterior Plane Block for Postoperative Analgesia After Breast Surgery: a Prospective Randomized Study
The application of regional anaesthetic procedures in breast surgery is associated with a lower incidence of chronic pain, reduced morbidity, shorter hospital stay and less opioid requirement. Therefore, we aimed to compared the postoperative analgesic efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in breast surgery.
Read the detailed description
Breast surgery is one of the most common operations performed by General Surgery and may be associated with acute postoperative pain. Acute postoperative pain is an independent risk factor for the development of chronic pain after mastectomy. Various regional anaesthetic procedures have been tried to achieve better acute pain control and thus less chronic pain. The use of regional anaesthetic procedures in breast surgery is associated with a lower incidence of chronic pain, reduced morbidity, shorter hospital stay and less opioid requirement.
Interfascial plane blocks have become popular because they are easy to perform and safe. Since interfascial plan blocks are based on the injection of local anaesthetic between two fasciae, the complication rate such as nerve damage is very low. With this method, effective analgesia can be provided in various areas such as abdominal, thoracic and lumbar regions while reducing opioid consumption and avoiding neuraxial methods.
In randomised controlled trials investigating the efficacy of Serratus Anterior Plane Block for postoperative analgesia management after breast surgery, adequate analgesia was reported.
Serratus posterior superior intercostal plan block, a newly defined interfascial plan block, has been shown to provide a wide sensory blockade between intercostal muscles. Postoperative analgesic efficacy has been demonstrated in thoracic, breast and shoulder surgeries.
The aim of our study was to compared the postoperative analgesic efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in breast surgery.
- Conditions
- Analgesia
- Being tested
- plane block with %0.25 30 ml bupivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plane block with %0.25 30 ml bupivacaineOther
Also called postoperative analgesia
evaluation of the efficacy of two different plan blocks for postoperative analgesia
| Study group | Role | What they receive |
|---|---|---|
| Patients with serratus posterior superior intercostal plan block | Active comparator | Serratus posterior superior intercostal plane block was applied to a certain group of patients for postoperative analgesia Receives: Other: plane block with %0.25 30 ml bupivacaine |
| Patients with serratus anterior plan block | Active comparator | Serratus anterior plane block was applied to a certain group of patients for postoperative analgesia Receives: Other: plane block with %0.25 30 ml bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of analgesic efficacy of postoperative plan blocks with numerical pain score (NRS)
Evaluation of which of the two plan blocks is more effective in postoperative analgesia.
Postoperative pain scores will be evaluated with a numerical pain score. Evaluation will be performed postoperatively at 1. hour, 4. hours, 8. hours, 12. hours and 24. hours. A lower numeric pain scale indicates a lower level of pain.
Measured: within 24 hours postoperative
Secondary outcomes (5)
Comparison of tramadol(mg) consumption
Using a patient-controlled analgesia device, tramadol consumption and total tramadol consumption will be compared between 0-1st hour, 1st-4th hour, 4th-8th hour, 8th-12th hour, 12th-24th hour postoperatively..
Measured: within 24 hours postoperative
perioperative remifentanil consumption
The amounts (mcg) of remifantanil consumed during the surgical procedure will be compared
Measured: perioperative
rescue anesthesia
In the postoperative 24-hour period, tenoxicam will be administered and recorded as rescue analgesia to patients who feel pain despite patient-controlled nalgesia (tramadol).
Measured: within 24 hours postoperative
postoperative nausea-vomiting (PONV)
The number of times of nausea and vomiting in the postoperative period will be recorded and compared in both patient groups. A lower numerical value of postoperative nausea-vomiting indicates better patient comfort in the postoperative period.
Measured: within 24 hours postoperative
patient satisfaction (5-point Likert scale)
At postoperative discharge, 5-point Likert satisfaction questionnaire will be administered to the patient. A high numerical value on a five-point Likert satisfaction scale indicates that the patient are satisfied with the procedure performed.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start13 Dec 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single blind
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Burgac
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mustafa Burgac, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436599
- Sponsor's protocol ID
- 2023/0870
- Status last verified
- Sep 2026
- First submitted
- 22 May 2024
- Last updated
- 1 Oct 2026
- 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Serratus Posterior Superior Intercostal Plane Block Versus Deep Serratus Anterior Plane Block for Postoperative Analgesia After Breast Surgery: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06436599
- Acronym / sponsor ID
- 2023/0870
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Mustafa BurgacUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 31 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.
The application of regional anaesthetic procedures in breast surgery is associated with a lower incidence of chronic pain, reduced morbidity, shorter hospital stay and less opioid requirement. Therefore, we aimed to compared the postoperative analgesic efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in breast surgery.
Detailed description
Breast surgery is one of the most common operations performed by General Surgery and may be associated with acute postoperative pain. Acute postoperative pain is an independent risk factor for the development of chronic pain after mastectomy. Various regional anaesthetic procedures have been tried to achieve better acute pain control and thus less chronic pain. The use of regional anaesthetic procedures in breast surgery is associated with a lower incidence of chronic pain, reduced morbidity, shorter hospital stay and less opioid requirement.
Interfascial plane blocks have become popular because they are easy to perform and safe. Since interfascial plan blocks are based on the injection of local anaesthetic between two fasciae, the complication rate such as nerve damage is very low. With this method, effective analgesia can be provided in various areas such as abdominal, thoracic and lumbar regions while reducing opioid consumption and avoiding neuraxial methods.
In randomised controlled trials investigating the efficacy of Serratus Anterior Plane Block for postoperative analgesia management after breast surgery, adequate analgesia was reported.
Serratus posterior superior intercostal plan block, a newly defined interfascial plan block, has been shown to provide a wide sensory blockade between intercostal muscles. Postoperative analgesic efficacy has been demonstrated in thoracic, breast and shoulder surgeries.
The aim of our study was to compared the postoperative analgesic efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in breast surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single blind
| Arm | Type | Receives |
|---|---|---|
| Patients with serratus posterior superior intercostal plan block | Active comparator | Other: plane block with %0.25 30 ml bupivacaineSerratus posterior superior intercostal plane block was applied to a certain group of patients for postoperative analgesia |
| Patients with serratus anterior plan block | Active comparator | Other: plane block with %0.25 30 ml bupivacaineSerratus anterior plane block was applied to a certain group of patients for postoperative analgesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- unilateral breast surgery
- ASA I-III risk group
Key exclusion criteria (6 listed)
- Coagulopathy
- Wound and infection in the block area
- Local anaesthetic allergy
- Mental retardation
- Non-cooperative
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 |
|---|---|---|
| plane block with %0.25 30 ml bupivacaineAlso: postoperative analgesiaevaluation of the efficacy of two different plan blocks for postoperative analgesia | Other | Patients with serratus anterior plan block, Patients with serratus posterior superior intercostal plan block |
Primary outcome
Evaluation of analgesic efficacy of postoperative plan blocks with numerical pain score (NRS)
Time frame: within 24 hours postoperative
Evaluation of which of the two plan blocks is more effective in postoperative analgesia. Postoperative pain scores will be evaluated with a numerical pain score. Evaluation will be performed postoperatively at 1. hour, 4. hours, 8. hours, 12. hours and 24. hours. A lower numeric pain scale indicates a lower level of pain.
5 secondary outcomes
Comparison of tramadol(mg) consumption
Time frame: within 24 hours postoperative
perioperative remifentanil consumption
Time frame: perioperative
rescue anesthesia
Time frame: within 24 hours postoperative
postoperative nausea-vomiting (PONV)
Time frame: within 24 hours postoperative
patient satisfaction (5-point Likert scale)
Time frame: 24 hours after surgery
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 1 Oct 2026.
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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 plane block with %0.25 30 ml bupivacaine in people with Analgesia, run by Mustafa Burgac 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 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 1 Oct 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?
Evaluation of analgesic efficacy of postoperative plan blocks with numerical pain score (NRS) (time frame: within 24 hours postoperative). 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 1 Oct 2026.