"Serratus Anterior Plane Block" Versus "Serratus Posterior Superior Plane Intercostal Plane Block" for Patients Undergoing Breast Surgery

NCT06711549 | Not Yet Recruiting

• 1 other identifier: 2024/Sapvsspis
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Serrato Posterosuperior Block (SPSIP) is a recently discovered technique that provides analgesia to the hemithorax, shoulders, neck and back. At an anatomical level, it has been seen that this technique allows the diffusion of local anesthetic starting from C7 proceeding dorsally up to T10 by sectioning the trapezius, latissimus dorsi, rhomboid and erector spinae muscles. The serratus anterior block (SAPB) is a technique that allows local anesthetic to be injected between the serratus anterior muscle and the intercostal muscles (deep plane) or between the latissimus dorsi muscle and the serratus anterior muscle (superficial plane), also providing analgesia at of the chest wall. This study aims to compare the analgesic efficacy of SPSIPB and SAPB in patients undergoing radical mastectomy for breast cancer

Conditions

Pain, Postoperative; Breast Cancer; Anesthesia; Mastectomy

Outcome Measures

Primary Outcomes (1)

• Pain at 0 hours after surgery

  The primary objective of the study is to evaluate whether there is a difference between SAP block and SPSIP block at 0 hours after surgery at rest measure with visual analogic scale (0-10)

  0 hours after surgery

Secondary Outcomes (6)

• Pain at 6 hours after surgery

  6 hours after surgery

• Pain at 12 hours after surgery

  12 hours after surgery

• Pain at 24hours after surgery

  24 hours after surgery

• Intraoperative Opioid consumption

  During the surgery(From patient intubation to patient extubation)

• Postoperative Opioid consumption

  From extubation to 24 hours post-enrollment

Study Arms (2)

Patients receiving Serratus Posterior Superior Plane Intercostal Plane block

EXPERIMENTAL

The patients will undergosurgery after receiving an ultrasound guided serratus posterior superior intercostal plane block

Procedure: Serratus Posterior Superior Plane Intercostal Plane block

Serratus Anterior Plane Block

ACTIVE COMPARATOR

The patients will undergosurgery after receiving an ultrasound guided serratus anterior plane block

Procedure: Serratus Anterior Plane block

Interventions

Serratus Posterior Superior Plane Intercostal Plane block PROCEDURE

Under ultrasound guidance; local anesthetic will be injected in the plane between the posterior aspect of the serratus posterior superior plane and the ribs

Patients receiving Serratus Posterior Superior Plane Intercostal Plane block

Serratus Anterior Plane block PROCEDURE

Under ultrasound guidance; local anesthetic will be injected in the plane between the posterior aspect of the serratus anterior and the external intercostal muscles and ribs

Serratus Anterior Plane Block

Eligibility Criteria

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

You may qualify if:

• Adult Patient ( \> 18 years)
• Informed consent
• American Society of Anaesthesiologis Phisical Status I to III
• Patients undergoing for mastectomy with sentinel lynphnode byopsy/axillary clearence

You may not qualify if:

• Pregnant women
• Allergy to any drug present in the protocol

Sponsors & Collaborators

• Ospedale di Camposampiero: lead
• Azienda Ulss 6 Euganea: collaborator

Related Publications (2)

• Rogobete AF, Sandesc D. General Anesthesia as a Multimodal Individualized Clinical Concept. Medicina (Kaunas). 2022 Jul 19;58(7):956. doi: 10.3390/medicina58070956.

  PMID: 35888675 RESULT

• Nelson G, Fotopoulou C, Taylor J, Glaser G, Bakkum-Gamez J, Meyer LA, Stone R, Mena G, Elias KM, Altman AD, Bisch SP, Ramirez PT, Dowdy SC. Enhanced recovery after surgery (ERAS(R)) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update. Gynecol Oncol. 2023 Jun;173:58-67. doi: 10.1016/j.ygyno.2023.04.009. Epub 2023 Apr 21.

  PMID: 37086524 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Breast Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Valentina Scaduto

CONTACT

3272217089; valentinascaduto@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: December 2, 2024
• Study Start: November 20, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share