Breast CancerNCT06750835
Efficacy of the Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Breast Cancer Surger.(SPSIP) Block is a Novel Regional Anesthesia Technique Targeting the Dorsal Rami and Intercostal Nerves (T2-T6), Providing Sensory Blockade to Both the Posterior and Lateral Aspect
A study testing SPSIP block, SAP block and Paravertebral block in people with Breast Cancer, run by Rehab Adel Ebrahim Okely.
Trial summary
The Serratus Posterior Superior Intercostal Plane (SPSIP) block is a novel regional anesthesia technique targeting the dorsal rami and intercostal nerves (T2-T6), providing sensory blockade to both the posterior and lateral aspects of the chest wall. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SPSIP block, SAP block and Paravertebral block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Oct 2027
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Female patients aged 18-75 years. 2. Scheduled for elective breast cancer surgery (MRM or BCS). 3. ASA physical status I-II. 4. Able to provide written informed consent.
- -
Who cannot join
- 1. Chronic pain conditions or long-term opioid use. 2. Coagulation disorders (platelets < 100,000/mm³ or INR > 1.5). 3. Severe obesity (BMI > 35 kg/m²). 4. Allergy to local anesthetics. 5. Anatomical abnormalities affecting block placement. 6. Pregnant or lactating women. 7. Active infection or skin lesions at the injection site.
- -
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
Official title: Efficacy of the Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Breast Cancer Surgery : A Randomized Comparative Study
The Serratus Posterior Superior Intercostal Plane (SPSIP) block is a novel regional anesthesia technique targeting the dorsal rami and intercostal nerves (T2-T6), providing sensory blockade to both the posterior and lateral aspects of the chest wall. By blocking these nerves at a more posterior location, the SPSIP block can potentially offer broader and more comprehensive analgesia for breast surgeries, including the axillary and deeper structures of the breast. This makes it a promising alternative or adjunct to the existing regional techniques used in breast cancer surgeries
Read the detailed description
Breast cancer is the most common malignancy among women worldwide, often requiring surgical intervention such as mastectomy or breast-conserving surgery. Despite advancements in surgical techniques, postoperative pain remains a significant concern, as inadequate pain management can lead to delayed recovery, increased opioid consumption, and a higher incidence of chronic pain conditions such as postmastectomy pain syndrome (PMPS). Effective pain control strategies are, therefore, crucial to enhancing patient recovery, reducing hospital stay, and improving overall quality of life [1].
Regional anesthesia techniques have gained prominence as an effective method for perioperative pain management in breast surgery [2]. Traditional blocks such as the Thoracic Paravertebral Block (TPVB) and Serratus Anterior Plane (SAP) Block have been extensively studied and are considered effective options for postoperative analgesia. However, these techniques are not without limitations [3]. The TPVB, although effective, carries a higher risk of complications such as pneumothorax and hypotension due to its proximity to the pleura. The SAP block, on the other hand, primarily provides analgesia to the lateral thoracic wall and may not adequately cover deeper breast tissues and posterior thoracic areas The current study aims to evaluate the efficacy of the SPSIP block for postoperative analgesia in breast cancer surgeries and to compare its analgesic profile with the SAP block and TPVB. By providing a comprehensive comparison, this study seeks to establish the SPSIP block as a viable and potentially superior option for postoperative pain management in breast cancer surgery.
> Patients and methods
- Type of the Study: This is a prospective, randomized controlled cohort study comparing the efficacy of the Serratus Posterior Superior Intercostal Plane (SPSIP) Block, Serratus Anterior Plane (SAP) Block, and Thoracic Paravertebral Block (PVB) for postoperative analgesia in breast cancer surgery.
- Study Setting: The study will be conducted at Assiut University Hospital, a tertiary care center equipped with advanced facilities for breast cancer surgeries and postoperative pain management.
- Conditions
- Breast Cancer
- Being tested
- SPSIP block, SAP block, Paravertebral block
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPSIP blockProcedure or surgery
Serratus posterior superior intercostal plane block
SAP blockProcedure or surgery
Serratus anterior plane block
Paravertebral blockProcedure or surgery
- The block will be administered under ultrasound guidance at the T2-T5 levels.
- A total of 15 mL of 0.25% bupivacaine will be injected into the paravertebral space on the side of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| SPSIP block | Active comparator | Serratus posterior superior intercostal plane block Receives: Procedure: SPSIP block |
| SAP block | Active comparator | Serratus anterior plane block Receives: Procedure: SAP block |
| Paravertebral block | Active comparator | Paravertebral block Receives: Procedure: Paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain relief
the level of postoperative pain as assessed by the Numerical Rating Scale (NRS) at rest and during movement at predefined intervals: 1 hour, 6 hours, 12 hours, and 24 hours post-surgery. The NRS is a validated tool that ranges from 0 (no pain) to 10 (worst imaginable pain).
Measured: 24 hours
Secondary outcomes (3)
Total Opioid Consumption
Measured: 24 hours
Time to First Analgesic Request
Measured: 24 hours
Incidence of Postoperative Nausea and Vomiting (PONV)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rehab Adel Ebrahim Okely
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rehab Adel Ebrahim Okely, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750835
- Sponsor's protocol ID
- SPSIP block in breast cancer
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Breast Cancer Surgery : A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT06750835
- Acronym / sponsor ID
- SPSIP block in breast cancer
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Rehab Adel Ebrahim OkelyUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 27 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 Serratus Posterior Superior Intercostal Plane (SPSIP) block is a novel regional anesthesia technique targeting the dorsal rami and intercostal nerves (T2-T6), providing sensory blockade to both the posterior and lateral aspects of the chest wall. By blocking these nerves at a more posterior location, the SPSIP block can potentially offer broader and more comprehensive analgesia for breast surgeries, including the axillary and deeper structures of the breast. This makes it a promising alternative or adjunct to the existing regional techniques used in breast cancer surgeries
Detailed description
Breast cancer is the most common malignancy among women worldwide, often requiring surgical intervention such as mastectomy or breast-conserving surgery. Despite advancements in surgical techniques, postoperative pain remains a significant concern, as inadequate pain management can lead to delayed recovery, increased opioid consumption, and a higher incidence of chronic pain conditions such as postmastectomy pain syndrome (PMPS). Effective pain control strategies are, therefore, crucial to enhancing patient recovery, reducing hospital stay, and improving overall quality of life [1].
Regional anesthesia techniques have gained prominence as an effective method for perioperative pain management in breast surgery [2]. Traditional blocks such as the Thoracic Paravertebral Block (TPVB) and Serratus Anterior Plane (SAP) Block have been extensively studied and are considered effective options for postoperative analgesia. However, these techniques are not without limitations [3]. The TPVB, although effective, carries a higher risk of complications such as pneumothorax and hypotension due to its proximity to the pleura. The SAP block, on the other hand, primarily provides analgesia to the lateral thoracic wall and may not adequately cover deeper breast tissues and posterior thoracic areas The current study aims to evaluate the efficacy of the SPSIP block for postoperative analgesia in breast cancer surgeries and to compare its analgesic profile with the SAP block and TPVB. By providing a comprehensive comparison, this study seeks to establish the SPSIP block as a viable and potentially superior option for postoperative pain management in breast cancer surgery.
> Patients and methods
- Type of the Study: This is a prospective, randomized controlled cohort study comparing the efficacy of the Serratus Posterior Superior Intercostal Plane (SPSIP) Block, Serratus Anterior Plane (SAP) Block, and Thoracic Paravertebral Block (PVB) for postoperative analgesia in breast cancer surgery.
- Study Setting: The study will be conducted at Assiut University Hospital, a tertiary care center equipped with advanced facilities for breast cancer surgeries and postoperative pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SPSIP block | Active comparator | Procedure: SPSIP blockSerratus posterior superior intercostal plane block |
| SAP block | Active comparator | Procedure: SAP blockSerratus anterior plane block |
| Paravertebral block | Active comparator | Procedure: Paravertebral blockParavertebral block |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Female patients aged 18-75 years. 2. Scheduled for elective breast cancer surgery (MRM or BCS). 3. ASA physical status I-II. 4. Able to provide written informed consent.
- -
Key exclusion criteria (2 listed)
- 1. Chronic pain conditions or long-term opioid use. 2. Coagulation disorders (platelets < 100,000/mm³ or INR > 1.5). 3. Severe obesity (BMI > 35 kg/m²). 4. Allergy to local anesthetics. 5. Anatomical abnormalities affecting block placement. 6. Pregnant or lactating women. 7. Active infection or skin lesions at the injection 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 |
|---|---|---|
| SPSIP blockSerratus posterior superior intercostal plane block | Procedure or surgery | SPSIP block |
| SAP blockSerratus anterior plane block | Procedure or surgery | SAP block |
| Paravertebral block* The block will be administered under ultrasound guidance at the T2-T5 levels. * A total of 15 mL of 0.25% bupivacaine will be injected into the paravertebral space on the side of the surgery. | Procedure or surgery | Paravertebral block |
Primary outcome
Post operative pain relief
Time frame: 24 hours
the level of postoperative pain as assessed by the Numerical Rating Scale (NRS) at rest and during movement at predefined intervals: 1 hour, 6 hours, 12 hours, and 24 hours post-surgery. The NRS is a validated tool that ranges from 0 (no pain) to 10 (worst imaginable pain).
3 secondary outcomes
Total Opioid Consumption
Time frame: 24 hours
Time to First Analgesic Request
Time frame: 24 hours
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: 24 hours
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 27 Dec 2024.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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 SPSIP block, SAP block and Paravertebral block in people with Breast Cancer, run by Rehab Adel Ebrahim Okely.
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 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 27 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 Rehab Adel Ebrahim (01099070718, Adelrehab273@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain relief (time frame: 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 27 Dec 2024.