Single-level and Two-level Serratus Posterior Superior Intercostal Plan Block (SPSIPB)

NCT06751407 | Not Yet Recruiting

• 1 other identifier: AEŞH-EK1-2024-0065
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Breast cancer is the most common malignancy in women; one of the mainstays of breast cancer treatment is surgery, and modified radical mastectomy is one of the standard treatments. Postoperative pain can seriously reduce the quality of life in patients, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abrigation during modified radical mastectomy, but their applications are limited due to the complex nature of the procedures and serious complications. In recent years, regional nerve blocks, including intercostal nerve block, erector spinae plane block (ESPB), and paravertebral block, PECS I-II block, serratus anterior plane block (SAPB), and Serratus Posterior Superior Intercostal Plane Block (SPSIPB), have been applied for the treatment of postmastectomy pain in breast cancer patients. SPSIPB has been frequently used for the treatment of acute pain in the postoperative period following surgeries in the thoracic region. SPSIPB is placed on the spine of the scapula in the sagittal plane to identify the second and third ribs under USG guidance. After visualizing the trapezius and serratus posterior superior (SPS) by moving medially to the upper medial border of the scapula, a block is applied to the depths of the SPS from above the 3rd rib. The applied local anesthetic solution spreads under the SPS muscle. Ipsilateral postoperative analgesia is provided with SPSIPB. SPSIPB can be applied on the 3rd rib in one go, or on the 3rd and 4th ribs in two go. Thus, the local anesthetic solution can be distributed more effectively and more effective postoperative analgesia can be provided.

Conditions

Opioid Consumption; Demographic Data

Keywords

serratus posterior superior intercostal plane block; pain; breast cancer; mastectomy

Outcome Measures

Primary Outcomes (1)

• Intraoperative opioid consumption.

  Intraoperative opioid consumption will be recorded.

  Intraoperative period

Secondary Outcomes (1)

• Postoperative 24-hour numeric rating scale

  postoperative 24 hours period

Study Arms (2)

Group Single level SPSIPB

ACTIVE COMPARATOR

The procedure will be performed with the patient in the prone position in the preoperative period. After the scapula is slightly shifted laterally, the US probe is held sagittally at the upper corner of the scapula spine, and the 3rd rib and the serratus posterior superior muscle will be visualized. In plane technique will be used. The block needle will be advanced in the caudo-cranial direction and entered between the serratus posterior superior and the 3rd rib. The block location will be confirmed by injecting 2 ml of saline between the rib and the muscle. After the block location is confirmed, 20 ml of 0.25% bupivacaine will be used.

Procedure: Single level SPSIPB

Group Two-level SPSIPB

ACTIVE COMPARATOR

The block needle will be advanced in the caudo-cranial direction and inserted between the serratus posterior superior and the 2nd rib. The block location will be confirmed by injecting 2 ml of saline between the rib and the muscle. After the block location is confirmed, 10 ml of 0.25% bupivacaine will be used. Then, the US probe will be held sagittally in the medial part of the scapula spine, and the 4th rib and serratus posterior superior muscle will be visualized. In plane technique will be used. The block needle will be advanced in the caudo-cranial direction and inserted between the serratus posterior superior and the 4th rib. The block location will be confirmed by injecting 2 ml of saline between the rib and the muscle. After the block site is confirmed, 10 ml of 0.25% bupivacaine will be used. A total of 20 ml of 0.25% bupivacaine will be used.

Procedure: Two-level SPSIPB

Interventions

Single level SPSIPB PROCEDURE

The procedure will be performed with the patient in the prone position in the preoperative period. After the scapula is slightly shifted laterally, the US probe is held sagittally at the upper corner of the scapula spine, and the 3rd rib and the serratus posterior superior muscle will be visualized. In plane technique will be used. The block needle will be advanced in the caudo-cranial direction and entered between the serratus posterior superior and the 3rd rib. The block location will be confirmed by injecting 2 ml of saline between the rib and the muscle. After the block location is confirmed, 20 ml of 0.25% bupivacaine will be used.

Group Single level SPSIPB

Two-level SPSIPB PROCEDURE

In plane technique will be used. The block needle will be advanced in the caudo-cranial direction and inserted between the serratus posterior superior and the 2nd rib. The block location will be confirmed by injecting 2 ml of saline between the rib and the muscle. After the block location is confirmed, 10 ml of 0.25% bupivacaine will be used. Then, the US probe will be held sagittally in the medial part of the scapula spine, and the 4th rib and serratus posterior superior muscle will be visualized. In plane technique will be used. The block needle will be advanced in the caudo-cranial direction and inserted between the serratus posterior superior and the 4th rib. The block location will be confirmed by injecting 2 ml of saline between the rib and the muscle. After the block site is confirmed, 10 ml of 0.25% bupivacaine will be used. A total of 20 ml of 0.25% bupivacaine will be used.

Group Two-level SPSIPB

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those between the ages of 18-80
• Those with ASA score I-II-III
• Those with body mass index (BMI) between 18-40
• Patients who underwent Single-Level or Two-Level SPSIPB together with mastectomy in the operating room

You may not qualify if:

• Those under 18 and over 80
• Those with ASA score IV and above
• Those with advanced co-morbidities
• Those with a history of bleeding diathesis
• Patients with infection in the area where the block will be performed
• Those with BMI under 18 and over 40
• Patients who underwent surgery under emergency conditions

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Related Publications (2)

• Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block for breast surgery: a report of three cases, novel block and new indication. Minerva Anestesiol. 2023 Nov;89(11):1054-1056. doi: 10.23736/S0375-9393.23.17432-3. Epub 2023 Jun 1. No abstract available.

  PMID: 37272274 BACKGROUND

• Kulturoglu G, Altinsoy S, Ozguner Y, Cataroglu CK. Novel Serratus Posterior Superior Intercostal Plane Block Provided Satisfactory Analgesia after Breast Cancer Surgery: Two Case Reports. Turk J Anaesthesiol Reanim. 2024 Feb 28;52(1):33-35. doi: 10.4274/TJAR.2024.231431.

  PMID: 38414179 BACKGROUND

MeSH Terms

Conditions

Pain; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 27, 2024
• Study Start: July 15, 2025
• Primary Completion: August 20, 2025
• Study Completion: September 10, 2025
• Last Updated: July 3, 2025

Record last verified: 2024-12