Pain, PostoperativeNCT06711549
"Serratus Anterior Plane Block" Versus "Serratus Posterior Superior Plane Intercostal Plane Block" for Patients Undergoing Breast Surgery
A study testing Serratus Posterior Superior Plane Intercostal Plane block and Serratus Anterior Plane block in people with Pain, Postoperative and Breast Cancer, run by Ospedale di Camposampiero.
Trial summary
The Serrato Posterosuperior Block (SPSIP) is a recently discovered technique that provides analgesia to the hemithorax, shoulders, neck and back. At an anatomical level, it has been seen that this technique allows the diffusion of local anesthetic starting from C7 proceeding dorsally up to T10 by sectioning the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative, Breast Cancer, Anesthesia
- What is being tested?
- Serratus Posterior Superior Plane Intercostal Plane block and Serratus Anterior Plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patient ( > 18 years)
- Informed consent
- American Society of Anaesthesiologis Phisical Status I to III
- Patients undergoing for mastectomy with sentinel lynphnode byopsy/axillary clearence
Who cannot join
- Pregnant women
- Allergy to any drug present in the protocol
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The Serrato Posterosuperior Block (SPSIP) is a recently discovered technique that provides analgesia to the hemithorax, shoulders, neck and back. At an anatomical level, it has been seen that this technique allows the diffusion of local anesthetic starting from C7 proceeding dorsally up to T10 by sectioning the trapezius, latissimus dorsi, rhomboid and erector spinae muscles. The serratus anterior block (SAPB) is a technique that allows local anesthetic to be injected between the serratus anterior muscle and the intercostal muscles (deep plane) or between the latissimus dorsi muscle and the serratus anterior muscle (superficial plane), also providing analgesia at of the chest wall. This study aims to compare the analgesic efficacy of SPSIPB and SAPB in patients undergoing radical mastectomy for breast cancer
- Conditions
- Pain, Postoperative, Breast Cancer, Anesthesia, Mastectomy
- Being tested
- Serratus Posterior Superior Plane Intercostal Plane block, Serratus Anterior Plane block
- Medical subject headings
- Pain, Postoperative, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Posterior Superior Plane Intercostal Plane blockProcedure or surgery
Under ultrasound guidance; local anesthetic will be injected in the plane between the posterior aspect of the serratus posterior superior plane and the ribs
Serratus Anterior Plane blockProcedure or surgery
Under ultrasound guidance; local anesthetic will be injected in the plane between the posterior aspect of the serratus anterior and the external intercostal muscles and ribs
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving Serratus Posterior Superior Plane Intercostal Plane block | Experimental | The patients will undergosurgery after receiving an ultrasound guided serratus posterior superior intercostal plane block Receives: Procedure: Serratus Posterior Superior Plane Intercostal Plane block |
| Serratus Anterior Plane Block | Active comparator | The patients will undergosurgery after receiving an ultrasound guided serratus anterior plane block Receives: Procedure: Serratus Anterior Plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at 0 hours after surgery
The primary objective of the study is to evaluate whether there is a difference between SAP block and SPSIP block at 0 hours after surgery at rest measure with visual analogic scale (0-10)
Measured: 0 hours after surgery
Secondary outcomes (6)
Pain at 6 hours after surgery
Evaluate whether there is a difference between SAP block and SPSIP block at 6 hours after surgery at rest measure with visual analogic scale (0-10)
Measured: 6 hours after surgery
Pain at 12 hours after surgery
Evaluate whether there is a difference between SAP block and SPSIP block at 12 hours after surgery at rest measure with visual analogic scale (0-10)
Measured: 12 hours after surgery
Pain at 24hours after surgery
Evaluate whether there is a difference between SAP block and SPSIP block at 24 hours after surgery at rest measure with visual analogic scale (0-10)
Measured: 24 hours after surgery
Intraoperative Opioid consumption
Intraoperative opioids consumption (remifentanyl measured as mcg/kg)
Measured: During the surgery(From patient intubation to patient extubation)
Postoperative Opioid consumption
Postoperative use of rescue analgesics (measured as yes or no)
Measured: From extubation to 24 hours post-enrollment
Postoperative Nausea and Vomiting
Postoperative Nausea and Vomiting defined as patient reporting nausea and vomiting or requiring drugs for nausea or vomiting
Measured: From extubation to 24 hours post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start20 Nov 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale di Camposampiero
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ulss 6 Euganea
- Responsible party
- Principal investigator, Valentina Scaduto, Ospedale di Camposampiero
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711549
- Sponsor's protocol ID
- 2024/Sapvsspis
- Status last verified
- Nov 2024
- First submitted
- 20 Oct 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rogobete AF, Sandesc D. General Anesthesia as a Multimodal Individualized Clinical Concept. Medicina (Kaunas). 2022 Jul 19;58(7):956. doi: 10.3390/medicina58070956.
PubMed 35888675Nelson G, Fotopoulou C, Taylor J, Glaser G, Bakkum-Gamez J, Meyer LA, Stone R, Mena G, Elias KM, Altman AD, Bisch SP, Ramirez PT, Dowdy SC. Enhanced recovery after surgery (ERAS(R)) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update. Gynecol Oncol. 2023 Jun;173:58-67. doi: 10.1016/j.ygyno.2023.04.009. Epub 2023 Apr 21.
PubMed 37086524
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Serratus Anterior Plane Block" Versus "Serratus Posterior Superior Plane Intercostal Plane Block" for Patients Undergoing Breast Surgery
- ClinicalTrials.gov ID
- NCT06711549
- Acronym / sponsor ID
- 2024/Sapvsspis
- Conditions
- Pain, Postoperative, Breast Cancer, Anesthesia, Mastectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Ospedale di CamposampieroUniversity, hospital or other
- Collaborators
- Azienda Ulss 6 Euganea
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 2 Dec 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 Serrato Posterosuperior Block (SPSIP) is a recently discovered technique that provides analgesia to the hemithorax, shoulders, neck and back. At an anatomical level, it has been seen that this technique allows the diffusion of local anesthetic starting from C7 proceeding dorsally up to T10 by sectioning the trapezius, latissimus dorsi, rhomboid and erector spinae muscles. The serratus anterior block (SAPB) is a technique that allows local anesthetic to be injected between the serratus anterior muscle and the intercostal muscles (deep plane) or between the latissimus dorsi muscle and the serratus anterior muscle (superficial plane), also providing analgesia at of the chest wall. This study aims to compare the analgesic efficacy of SPSIPB and SAPB in patients undergoing radical mastectomy for breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving Serratus Posterior Superior Plane Intercostal Plane block | Experimental | Procedure: Serratus Posterior Superior Plane Intercostal Plane blockThe patients will undergosurgery after receiving an ultrasound guided serratus posterior superior intercostal plane block |
| Serratus Anterior Plane Block | Active comparator | Procedure: Serratus Anterior Plane blockThe patients will undergosurgery after receiving an ultrasound guided serratus anterior plane block |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult Patient ( > 18 years)
- Informed consent
- American Society of Anaesthesiologis Phisical Status I to III
- Patients undergoing for mastectomy with sentinel lynphnode byopsy/axillary clearence
Key exclusion criteria (2 listed)
- Pregnant women
- Allergy to any drug present in the protocol
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 Plane Intercostal Plane blockUnder ultrasound guidance; local anesthetic will be injected in the plane between the posterior aspect of the serratus posterior superior plane and the ribs | Procedure or surgery | Patients receiving Serratus Posterior Superior Plane Intercostal Plane block |
| Serratus Anterior Plane blockUnder ultrasound guidance; local anesthetic will be injected in the plane between the posterior aspect of the serratus anterior and the external intercostal muscles and ribs | Procedure or surgery | Serratus Anterior Plane Block |
Primary outcome
Pain at 0 hours after surgery
Time frame: 0 hours after surgery
The primary objective of the study is to evaluate whether there is a difference between SAP block and SPSIP block at 0 hours after surgery at rest measure with visual analogic scale (0-10)
6 secondary outcomes
Pain at 6 hours after surgery
Time frame: 6 hours after surgery
Pain at 12 hours after surgery
Time frame: 12 hours after surgery
Pain at 24hours after surgery
Time frame: 24 hours after surgery
Intraoperative Opioid consumption
Time frame: During the surgery(From patient intubation to patient extubation)
Postoperative Opioid consumption
Time frame: From extubation to 24 hours post-enrollment
Postoperative Nausea and Vomiting
Time frame: From extubation to 24 hours post-enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Results publication: PubMed 35888675Rogobete AF, Sandesc D. General Anesthesia as a Multimodal Individualized Clinical Concept. Medicina (Kaunas). 2022 Jul 19;58(7):956. doi: 10.3390/medicina58070956.
- Results publication: PubMed 37086524Nelson G, Fotopoulou C, Taylor J, Glaser G, Bakkum-Gamez J, Meyer LA, Stone R, Mena G, Elias KM, Altman AD, Bisch SP, Ramirez PT, Dowdy SC. Enhanced recovery after surgery (ERAS(R)) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update. Gynecol Oncol. 2023 Jun;173:58-67. doi: 10.1016/j.ygyno.2023.04.009. Epub 2023 Apr 21.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus Posterior Superior Plane Intercostal Plane block and Serratus Anterior Plane block in people with Pain, Postoperative and Breast Cancer, run by Ospedale di Camposampiero.
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 2 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: opening soon, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentina Scaduto (3272217089 ext. +390499424898, valentinascaduto@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain at 0 hours after surgery (time frame: 0 hours 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 NCT06711549, which also lists 2 linked publications.
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 Dec 2024.