AzTrials
AzTrials

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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06225908
Study groupRoleWhat they receive
Group ControlNo interventionNot described
Group SPSİPBActive comparatorNot 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.

  1. opioid consumption

    total consumption of opioid during 24 hour after surgery

    Measured: up to 24 hour after surgery

Secondary outcomes (1)
  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.

  1. First posted26 Jan 2024
  2. Study start18 Jan 2024
  3. Primary completion30 Mar 2024
  4. Study completion1 May 2024

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in