Clinical trial NCT06711549: "Serratus Anterior Plane Block" Versus "Serratus Posterior Superior Plane Intercostal Plane Block" for Patients Undergoing Breast Surgery
Official title: "Serratus Anterior Plane Block" Versus "Serratus Posterior Superior Plane Intercostal Plane Block" for Patients Undergoing Breast Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Breast Cancer
Anesthesia
Mastectomy
Lead sponsor: Ospedale di Camposampiero
Sponsor class: OTHER
Collaborators: name: Azienda Ulss 6 EUGANEA
First posted: 2024-12-02
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Pain at 0 hours after surgery
timeFrame: 0 hours after surgery
Secondary outcomes:
measure: Pain at 6 hours after surgery
timeFrame: 6 hours after surgery
measure: Pain at 12 hours after surgery
timeFrame: 12 hours after surgery
measure: Pain at 24hours after surgery
timeFrame: 24 hours after surgery
measure: Intraoperative Opioid consumption
timeFrame: During the surgery(From patient intubation to patient extubation)
measure: Postoperative Opioid consumption
timeFrame: From extubation to 24 hours post-enrollment
measure: Postoperative Nausea and Vomiting
timeFrame: From extubation to 24 hours post-enrollment
Other outcomes:
Locations:
Study officials:
References:
citation: Rogobete AF, Sandesc D. General Anesthesia as a Multimodal Individualized Clinical Concept. Medicina (Kaunas). 2022 Jul 19;58(7):956. doi: 10.3390/medicina58070956.
citation: 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.