Serratus Posterior Superior Intercostal Plane Block, Versus Erector Spinae Facial Plane Blocks

NCT ID: NCT06989372

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-09-01

Brief Summary

Mastectomy is currently the most effective treatment for breast cancers in women. postoperative pain management carries a high degree of difficulty, as the breast has complex innervation involving the intercostal (T1-T7), superficial cervical plexus (supraclavicular nerves) and brachial plexus .While severe acute pain is observed in approximately 40% of post-mastectomy patients, moderate-to-severe pain is observed in almost one-third of them .

Conditions

Breast Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Group I (SP)

serratus posterior superior block

Group Type: ACTIVE_COMPARATOR

serratus posterior superior block

Intervention Type: PROCEDURE

patients were placed in the lateral decubitus position for SPSIPB. The blocks were performed under the guidance of ultrasonography (USG), a high-frequency linear probe (SonoSite HFL50x, 15-6 MHz, 55-mm broadband linear array, USA) transducer was placed at the level of the spine scapula in the transverse plane, and the upper medial border of the scapula, trapezius muscle, serratus posterior superior muscle (SPSM), 2nd and 3rd ribs were visualized. The ultrasound probe is rotated 90 degrees in a parasagittal orientation to identify the first rib. After its identification, the second and third ribs are confirmed. An 80 mm sono visible needle (type) was inserted in the caudocranial direction just medial to the scapula with the in-plane technique and driven between the 2nd and 3rd ribs targeting the inferior part of the SPSM. The target was confirmed by injecting the test dose with saline. Thirty ml of 0.25% bupivacaine was subsequently injected

Group II (ES)

erector spinae block

Group Type: ACTIVE_COMPARATOR

erector spinae block

Intervention Type: PROCEDURE

US-guided ESPB, a commonly performed interfascial plane block, was first defined by Forero et al. (21). In this technique, LA is injected in the plane between the erector spinae muscles and the thoracic transverse processes. Thus, multiple thoracic levels are anesthetized by the LA spreading in a craniocaudal direction. The transducer was then placed approximately 3 cm lateral to the midline parasagittally. The T5 transverse process and the erector spinae, rhomboid major, trapezius muscles were viewed (i.e., from deep to superficial). The block needle was advanced in a craniocaudal direction using an in-plane approach through the trapezius, rhomboid major, and erector spinae muscles. After establishing contact with the hyperechoic transverse process, 30 mL of 0.25% bupivacaine was injected in small aliquots after hydrodissection (2-3 mL, 0.9% NaCl) and checking for negative blood aspiration after every 5 mL of injection.

Interventions

serratus posterior superior block

patients were placed in the lateral decubitus position for SPSIPB. The blocks were performed under the guidance of ultrasonography (USG), a high-frequency linear probe (SonoSite HFL50x, 15-6 MHz, 55-mm broadband linear array, USA) transducer was placed at the level of the spine scapula in the transverse plane, and the upper medial border of the scapula, trapezius muscle, serratus posterior superior muscle (SPSM), 2nd and 3rd ribs were visualized. The ultrasound probe is rotated 90 degrees in a parasagittal orientation to identify the first rib. After its identification, the second and third ribs are confirmed. An 80 mm sono visible needle (type) was inserted in the caudocranial direction just medial to the scapula with the in-plane technique and driven between the 2nd and 3rd ribs targeting the inferior part of the SPSM. The target was confirmed by injecting the test dose with saline. Thirty ml of 0.25% bupivacaine was subsequently injected

Intervention Type: PROCEDURE

erector spinae block

US-guided ESPB, a commonly performed interfascial plane block, was first defined by Forero et al. (21). In this technique, LA is injected in the plane between the erector spinae muscles and the thoracic transverse processes. Thus, multiple thoracic levels are anesthetized by the LA spreading in a craniocaudal direction. The transducer was then placed approximately 3 cm lateral to the midline parasagittally. The T5 transverse process and the erector spinae, rhomboid major, trapezius muscles were viewed (i.e., from deep to superficial). The block needle was advanced in a craniocaudal direction using an in-plane approach through the trapezius, rhomboid major, and erector spinae muscles. After establishing contact with the hyperechoic transverse process, 30 mL of 0.25% bupivacaine was injected in small aliquots after hydrodissection (2-3 mL, 0.9% NaCl) and checking for negative blood aspiration after every 5 mL of injection.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• age 18 to 65 years
• ASA classification I and II

Exclusion Criteria

• age below 18 or above 65 years
• ASA classification III or more

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Shabayek

Lecturer of Anesthesia, ICU and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU R68/2025

Identifier Type: -

Identifier Source: org_study_id