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Not yet recruiting NCT06711549

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

No phase Interventional Pain, Postoperative Breast Cancer Anesthesia Mastectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Serratus Posterior Superior Plane Intercostal Plane block, Serratus Anterior Plane block.
Who it may be relevant to
Registry conditions: Pain, Postoperative, Breast Cancer, Anesthesia, Mastectomy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • 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
  • 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

Primary outcome measures

  • Pain at 0 hours after surgery [Time frame: 0 hours after surgery]
Secondary outcome measures (6)
  • Pain at 6 hours after surgery [Time frame: 6 hours after surgery]
  • Pain at 12 hours after surgery [Time frame: 12 hours after surgery]
  • Pain at 24hours after surgery [Time frame: 24 hours after surgery]
  • Intraoperative Opioid consumption [Time frame: During the surgery(From patient intubation to patient extubation)]
  • Postoperative Opioid consumption [Time frame: From extubation to 24 hours post-enrollment]
  • Postoperative Nausea and Vomiting [Time frame: From extubation to 24 hours post-enrollment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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
  • 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

Identifiers

NCT: NCT06711549 · 2024/Sapvsspis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗