Pain, PostoperativeNCT06225908
SPSIPB for Breast Cancer Surgery
A study testing Serratus posterior superior intercostal plane block in people with Pain, Postoperative and Pain, Acute, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
Acute postoperative pain after breast cancer surgery is usually moderate to severe, and inadequate postoperative pain management can significantly increase perioperative analgesic consumption, prolong hospital stay, and even cause long-term persistent pain such as postmastectomy pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Pain, Acute, Opioid Consumption
- What is being tested?
- 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
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2024to 1 May 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years old
- ASA I-II-III risk group
- Patients whose consent was obtained with an informed consent form
- Breast Cancer Surgery operation patients who will undergo
Who cannot join
- Under 18 and over 65
- ASA ≥ IV
- History of allergy to local anesthetics
- Known coagulation disorders
- Infection near the entry site
- Chronic use of analgesics
Show all 10Show fewer
- Diabetes Mellitus and patients receiving neoadjuvant chemotherapy
- Body Mass index over 30
- Dementia or confusion
- Lack of cooperation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zongulak Bülent Ecevit University
Zonguldak, Kozlu, 67600
About this study
Official title: The Effects of Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia in Patients Undergoing Breast Cancer Surgery
Acute postoperative pain after breast cancer surgery is usually moderate to severe, and inadequate postoperative pain management can significantly increase perioperative analgesic consumption, prolong hospital stay, and even cause long-term persistent pain such as postmastectomy pain syndrome. A multimodal analgesic approach (NSAII, paracetamol, opioids, local infiltration, facial plane blocks and paravertebral and periparavertebral blocks) is recommended.
Paravertebral block (PVB) is considered the gold standard analgesic method for breast surgery. However, PVB is an invasive block requiring advanced skills and deep injection in close proximity to the pleura, intercostal nerves, neuraxis, great vessels and intercostal neurovascular bundles. As a result, the ongoing risks of pneumothorax, neuraxial spread, hypotension and systemic toxicity preclude its routine use in the day surgery setting. Therefore, alternative blocks have been developed. Various regional techniques such as Serratus plan block (SPB), interpectoral/pectoroserratus blocks (PECS I/II), erector spina plan block (ESPB) and rhomboid intercostal plan block (RIB) have been used to relieve pain after breast surgery. However, local anesthetic distribution may be affected by the surgical incision in the chest muscles. ESPB can be performed from cervical to sacral vertebrae, but clinical, cadaveric and radiologic results are inconsistent. RIB provides hemithoracic analgesia; however, RIB does not cover the cranial aspect of the T2 dermatome. A meta-analysis reported that SPB effectively relieves acute postoperative pain, reduces nausea and vomiting, and improves perioperative anesthesia outcomes in breast surgery. In another study compared with placebo, it was reported that serratus plane block provided less pain at rest, but there was no significant difference in reducing postoperative opioid consumption.
Read more
Serratus Posterior Superior Intercostal Plan Block is performed in the fascial plane between the serratus posterior superior muscle and intercostal muscles at the second and third costal level. SPSIB provides hemithoracic analgesia from the paraspinal region to the anteromedial region of the chest wall including the axillary region. In a case series of patients undergoing breast surgery, it was reported that the costal plane plays an important role in preventing pneumothorax, provides a natural barrier to the pleura, and may be a good choice for postoperative analgesia management as part of multimodal analgesia after breast surgery.
In this study, the investigators aimed to observationally investigate the effect of serratus posterior superior intercostal plane block on postoperative opioid consumption in patients undergoing breast cancer surgery under general anesthesia.
- Conditions
- Pain, Postoperative, Pain, Acute, Opioid Consumption
- Being tested
- Serratus posterior superior intercostal plane block
- Keywords
- breast surgery, pain management
- Medical subject headings
- Pain, Postoperative, Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus posterior superior intercostal plane blockProcedure or surgery
application of local anestesic under serratus posterior superior muscle at the level of second costa
| Study group | Role | What they receive |
|---|---|---|
| Group Control | No intervention | Not described |
| Group SPSİPB | Active comparator | Not described 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.
opioid consumption
total consumption of opioid during 24 hour after surgery
Measured: up to 24 hour after surgery
Secondary outcomes (1)
Pain scores
Patient's pain intensity by using numeric rating scale score
Measured: up to 24 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start18 Jan 2024
- Primary completion30 Mar 2024
- Study completion1 May 2024
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 Pain, PostoperativeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengü Gülhan Köksal, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225908
- Sponsor's protocol ID
- 2023-12-13/12
- Status last verified
- Mar 2025
- First submitted
- 17 Jan 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koksal BG, Baytar C, Bayraktar E, Balbaloglu H. Effects of serratus posterior superior intercostal plane block on postoperative analgesia in patients undergoing breast cancer surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Apr 24;25(1):209. doi: 10.1186/s12871-025-03092-0.
PubMed 40275145
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia in Patients Undergoing Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT06225908
- Acronym / sponsor ID
- 2023-12-13/12
- Conditions
- Pain, Postoperative, Pain, Acute, Opioid Consumption
- Keywords
- breast surgery, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 26 Jan 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.
Acute postoperative pain after breast cancer surgery is usually moderate to severe, and inadequate postoperative pain management can significantly increase perioperative analgesic consumption, prolong hospital stay, and even cause long-term persistent pain such as postmastectomy pain syndrome. A multimodal analgesic approach (NSAII, paracetamol, opioids, local infiltration, facial plane blocks and paravertebral and periparavertebral blocks) is recommended.
Paravertebral block (PVB) is considered the gold standard analgesic method for breast surgery. However, PVB is an invasive block requiring advanced skills and deep injection in close proximity to the pleura, intercostal nerves, neuraxis, great vessels and intercostal neurovascular bundles. As a result, the ongoing risks of pneumothorax, neuraxial spread, hypotension and systemic toxicity preclude its routine use in the day surgery setting. Therefore, alternative blocks have been developed. Various regional techniques such as Serratus plan block (SPB), interpectoral/pectoroserratus blocks (PECS I/II), erector spina plan block (ESPB) and rhomboid intercostal plan block (RIB) have been used to relieve pain after breast surgery. However, local anesthetic distribution may be affected by the surgical incision in the chest muscles. ESPB can be performed from cervical to sacral vertebrae, but clinical, cadaveric and radiologic results are inconsistent. RIB provides hemithoracic analgesia; however, RIB does not cover the cranial aspect of the T2 dermatome. A meta-analysis reported that SPB effectively relieves acute postoperative pain, reduces nausea and vomiting, and improves perioperative anesthesia outcomes in breast surgery. In another study compared with placebo, it was reported that serratus plane block provided less pain at rest, but there was no significant difference in reducing postoperative opioid consumption.
Serratus Posterior Superior Intercostal Plan Block is performed in the fascial plane between the serratus posterior superior muscle and intercostal muscles at the second and third costal level. SPSIB provides hemithoracic analgesia from the paraspinal region to the anteromedial region of the chest wall including the axillary region. In a case series of patients undergoing breast surgery, it was reported that the costal plane plays an important role in preventing pneumothorax, provides a natural barrier to the pleura, and may be a good choice for postoperative analgesia management as part of multimodal analgesia after breast surgery.
In this study, the investigators aimed to observationally investigate the effect of serratus posterior superior intercostal plane block on postoperative opioid consumption in patients undergoing breast cancer surgery under general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Control | No intervention | – |
| Group SPSİPB | Active comparator | Procedure: Serratus posterior superior intercostal plane block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years old
- ASA I-II-III risk group
- Patients whose consent was obtained with an informed consent form
- Breast Cancer Surgery operation patients who will undergo
Key exclusion criteria (10 listed)
- Under 18 and over 65
- ASA ≥ IV
- History of allergy to local anesthetics
- Known coagulation disorders
- Infection near the entry site
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 |
|---|---|---|
| Serratus posterior superior intercostal plane blockapplication of local anestesic under serratus posterior superior muscle at the level of second costa | Procedure or surgery | Group SPSİPB |
Primary outcome
opioid consumption
Time frame: up to 24 hour after surgery
total consumption of opioid during 24 hour after surgery
1 secondary outcome
Pain scores
Time frame: up to 24 hour 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 2 Apr 2025.
- Derived from this study: PubMed 40275145Koksal BG, Baytar C, Bayraktar E, Balbaloglu H. Effects of serratus posterior superior intercostal plane block on postoperative analgesia in patients undergoing breast cancer surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Apr 24;25(1):209. doi: 10.1186/s12871-025-03092-0.
- 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 Serratus posterior superior intercostal plane block in people with Pain, Postoperative and Pain, Acute, run by Zonguldak Bulent Ecevit 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 10 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 2 Apr 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?
opioid consumption (time frame: up to 24 hour after 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 NCT06225908, 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 2 Apr 2025; AzTrials last refreshed its copy on 31 Oct 2026.