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

Not Applicable

Not yet recruiting

• Conditions: Pain, Postoperative; Breast Cancer; Anesthesia; Mastectomy

• Registration Number: NCT06711549
• Lead Sponsor: Ospedale di Camposampiero

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-20
• Status Verified: 2024-11
• Study Start: 2024-11-20
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain at 0 hours after surgery	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)

Secondary Outcome Measures

Name	Time	Method
Pain at 6 hours after surgery	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)
Pain at 12 hours after surgery	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)
Pain at 24hours after surgery	24 hours 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)
Intraoperative Opioid consumption	During the surgery(From patient intubation to patient extubation)	Intraoperative opioids consumption (remifentanyl measured as mcg/kg)
Postoperative Opioid consumption	From extubation to 24 hours post-enrollment	Postoperative use of rescue analgesics (measured as yes or no)
Postoperative Nausea and Vomiting	From extubation to 24 hours post-enrollment	Postoperative Nausea and Vomiting defined as patient reporting nausea and vomiting or requiring drugs for nausea or vomiting