Postmastectomy PainSPSIPBNCT06100419
SPSIP Block in Breast Surgeries for Postoperative Analgesia
A study testing serratus posterior superior intercostal plane block in people with Postmastectomy Pain, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study is to demonstrate that pain following breast surgeries can be reduced through the application of serratus posterior superior intercostal plane block (SPSIPB). Seven patients scheduled for breast surgery were included in the study. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmastectomy Pain
- 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
- 7 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jun 2023to 22 Jul 2023
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Female patients who will undergo breast surgery
Who cannot join
- unstable patients
- patients with bleeding disorders
- Patients allergic to local anesthetic drugs
- Patients who did not agree to participate in the study
- Patients with infection at the application site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Serratus Posterior Superior Intercostal Plane Block Effective in Modified Radical Mastectomy Surgeries?
The aim of this clinical study is to demonstrate that pain following breast surgeries can be reduced through the application of serratus posterior superior intercostal plane block (SPSIPB). Seven patients scheduled for breast surgery were included in the study. The primary research question it seeks to address is as follows: • Can SPSIPB be applied to reduce pain following breast surgeries? Participants are expected to provide accurate responses to the researcher's questions for the assessment of postoperative pain.
Read the detailed description
Postoperative analgesia techniques for breast surgeries encompass options such as Paravertebral Block, Erector Spinae Plane Block, Serratus Anterior Plane Block, and Pectoral Nerve Blocks. Although the Paravertebral Block is considered the gold standard for postmastectomy pain relief, its limited usage is primarily attributed to complications. SPSIPB's potential in thoracic surgeries has been noted, offering a broad sensory block suitable for MRM and axillary lymph node dissection. In this study, the effectiveness of SPSIP block for post-mastectomy pain has been investigated.
- Conditions
- Postmastectomy Pain
- Being tested
- serratus posterior superior intercostal plane block
- Keywords
- serratus posterior superior intercostal plane block, regional anaesthesia, postmastectomy pain, interfascial plane blocks
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
Also called SPSIPB
With this newly introduced procedure added to the literature, patients undergoing breast surgeries are expected to experience reduced pain.
| Study group | Role | What they receive |
|---|---|---|
| Block | Experimental | This group consists of patients who underwent SPSIP block. 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.
numeric rate scores (NRS)
The pain levels of patients are indicated with a number between 1 and 10. its means: 0=no pain, 10=worst pain.
Measured: first 24 hours
Secondary outcomes (1)
total tramadol consumption
The total analgesic quantity that patients will consume for pain reduction.
Measured: first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start22 Jun 2023
- Primary completion22 Jul 2023
- Study completion22 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmastectomy PainStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- case series
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Balci, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100419
- Sponsor's protocol ID
- SPSIPB
- Acronym
- SPSIPB
- Status last verified
- Oct 2023
- First submitted
- 14 Oct 2023
- Last updated
- 26 Oct 2023
- 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 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Serratus Posterior Superior Intercostal Plane Block Effective in Modified Radical Mastectomy Surgeries?
- ClinicalTrials.gov ID
- NCT06100419
- Acronym / sponsor ID
- SPSIPB / SPSIPB
- Conditions
- Postmastectomy Pain
- Keywords
- serratus posterior superior intercostal plane block, regional anaesthesia, postmastectomy pain, interfascial plane blocks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 22 Jul 2023 (actual)
- First posted
- 25 Oct 2023 (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 aim of this clinical study is to demonstrate that pain following breast surgeries can be reduced through the application of serratus posterior superior intercostal plane block (SPSIPB). Seven patients scheduled for breast surgery were included in the study. The primary research question it seeks to address is as follows: • Can SPSIPB be applied to reduce pain following breast surgeries? Participants are expected to provide accurate responses to the researcher's questions for the assessment of postoperative pain.
Detailed description
Postoperative analgesia techniques for breast surgeries encompass options such as Paravertebral Block, Erector Spinae Plane Block, Serratus Anterior Plane Block, and Pectoral Nerve Blocks. Although the Paravertebral Block is considered the gold standard for postmastectomy pain relief, its limited usage is primarily attributed to complications. SPSIPB's potential in thoracic surgeries has been noted, offering a broad sensory block suitable for MRM and axillary lymph node dissection. In this study, the effectiveness of SPSIP block for post-mastectomy pain has been investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- case series
| Arm | Type | Receives |
|---|---|---|
| Block | Experimental | Procedure: serratus posterior superior intercostal plane blockThis group consists of patients who underwent SPSIP block. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients who will undergo breast surgery
Key exclusion criteria (5 listed)
- unstable patients
- patients with bleeding disorders
- Patients allergic to local anesthetic drugs
- Patients who did not agree to participate in the study
- Patients with infection at the application 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 blockAlso: SPSIPBWith this newly introduced procedure added to the literature, patients undergoing breast surgeries are expected to experience reduced pain. | Procedure or surgery | Block |
Primary outcome
numeric rate scores (NRS)
Time frame: first 24 hours
The pain levels of patients are indicated with a number between 1 and 10. its means: 0=no pain, 10=worst pain.
1 secondary outcome
total tramadol consumption
Time frame: first 24 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 26 Oct 2023.
- 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 Postmastectomy Pain, run by Cumhuriyet 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 1 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 26 Oct 2023. 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?
numeric rate scores (NRS) (time frame: first 24 hours). 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 26 Oct 2023.