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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

NCT ID: NCT06750835

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2027-10-31

Brief Summary

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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

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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

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SPSIP block

Serratus posterior superior intercostal plane block

Group Type ACTIVE_COMPARATOR

SPSIP block

Intervention Type PROCEDURE

Serratus posterior superior intercostal plane block

SAP block

Serratus anterior plane block

Group Type ACTIVE_COMPARATOR

SAP block

Intervention Type PROCEDURE

Serratus anterior plane block

Paravertebral block

Paravertebral block

Group Type ACTIVE_COMPARATOR

Paravertebral block

Intervention Type PROCEDURE

* 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.

Interventions

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SPSIP block

Serratus posterior superior intercostal plane block

Intervention Type PROCEDURE

SAP block

Serratus anterior plane block

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.

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Exclusion Criteria

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.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rehab Adel Ebrahim Okely

OTHER

Sponsor Role lead

Responsible Party

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Rehab Adel Ebrahim Okely

Assistant lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Rehab Adel Ebrahim

Role: CONTACT

Phone: 01099070718

Email: [email protected]

Other Identifiers

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SPSIP block in breast cancer

Identifier Type: -

Identifier Source: org_study_id