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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative; Breast Cancer; Anesthesia; Mastectomy
• Intervention / Treatment: Procedure: Serratus Posterior Superior Plane Intercostal Plane block; Procedure: Serratus Anterior Plane block

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valentina Scaduto; Phone Number: +390499424898 3272217089; Email: valentinascaduto@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients receiving Serratus Posterior Superior Plane Intercostal Plane block; The patients will undergosurgery after receiving an ultrasound guided serratus posterior superior intercostal plane block	Procedure: Serratus Posterior Superior Plane Intercostal Plane block; Under ultrasound guidance; local anesthetic will be injected in the plane between the posterior aspect of the serratus posterior superior plane and the ribs
Active Comparator: Serratus Anterior Plane Block; The patients will undergosurgery after receiving an ultrasound guided serratus anterior plane block	Procedure: Serratus Anterior Plane block; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at 6 hours after surgery	Evaluate whether there is a difference between SAP block and SPSIP block at 6 hours after surgery at rest measure with visual analogic scale (0-10)	6 hours after surgery
Pain at 12 hours after surgery	Evaluate whether there is a difference between SAP block and SPSIP block at 12 hours after surgery at rest measure with visual analogic scale (0-10)	12 hours after surgery
Pain at 24hours after surgery	Evaluate whether there is a difference between SAP block and SPSIP block at 24 hours after surgery at rest measure with visual analogic scale (0-10)	24 hours after surgery
Intraoperative Opioid consumption	Intraoperative opioids consumption (remifentanyl measured as mcg/kg)	During the surgery(From patient intubation to patient extubation)
Postoperative Opioid consumption	Postoperative use of rescue analgesics (measured as yes or no)	From extubation to 24 hours post-enrollment
Postoperative Nausea and Vomiting	Postoperative Nausea and Vomiting defined as patient reporting nausea and vomiting or requiring drugs for nausea or vomiting	From extubation to 24 hours post-enrollment

Collaborators and Investigators

• Sponsor: Ospedale di Camposampiero
• Collaborators: Azienda Ulss 6 Euganea

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Estimated): November 20, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 20, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Estimated): December 2, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: 2024/Sapvsspis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No