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
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interventional
90
0 countries
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Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Jan 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2024
CompletedFirst Posted
Study publicly available on registry
December 27, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
December 27, 2024
December 1, 2024
1.7 years
December 20, 2024
December 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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).
24 hours
Secondary Outcomes (3)
Total Opioid Consumption
24 hours
Time to First Analgesic Request
24 hours
Incidence of Postoperative Nausea and Vomiting (PONV)
24 hours
Study Arms (3)
SPSIP block
ACTIVE COMPARATORSerratus posterior superior intercostal plane block
SAP block
ACTIVE COMPARATORSerratus anterior plane block
Paravertebral block
ACTIVE COMPARATORParavertebral block
Interventions
* 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.
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
December 20, 2024
First Posted
December 27, 2024
Study Start
January 1, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2027
Last Updated
December 27, 2024
Record last verified: 2024-12