Clinical trial · Interventional
Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection
Assessment of the Feasibility of Ultrasound Guided Serratus Plane Block Associated With Sedation as Anesthetic Technique in Axillary Dissection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
INTRODUCTION: The axillary lymphadenectomy procedure is known to be associated with late postoperative complications, such as chronic pain and changes in shoulder mobility. Recently, several thoracic ultrasound guided interfascial blocks have been described, including serratus plane block. These blocks were associated with reduced postoperative pain scores in breast surgeries but were never evaluated in axillary dissection. The safety and feasibility of performing axillary dissection under local anesthesia and tumescent anesthesia associated with sedation has been demonstrated in case series, although it is not already the standard technique. DISCUSSION: This project aims to investigate the feasibility of the serratus plane block associated with intra-venous sedation in a prospective case series including 15 patients submitted to axillary dissection, by scoring patient and surgeon satisfaction with the technique, pain, quality of life with EORTC QLQ-C30 questionnaire, and quality of recovery with QoR-40 questionnaire in the first 30 postoperative days.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Analgesia | — | UNRESOLVED | — |
| Anesthesia | — | UNRESOLVED | — |
| Axillary Metastases | — | UNRESOLVED | — |
| Nerve Block | — | UNRESOLVED | — |
| Regional Anesthesia Morbidity | — | UNRESOLVED | — |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axillary dissection | Procedure | — | UNRESOLVED |
| Intravenous sedation | Procedure | — | UNRESOLVED |
| Serratus plane block | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Serratus plane block plus sedation
- description
- Serratus plane block plus intravenous sedation as anesthetic technique during axillary dissection procedure.
- interventionNames
- Procedure: Serratus plane block
- Procedure: Axillary dissection
- Procedure: Intravenous sedation
Primary outcomes (1)
- measure
- Percentage of patients who needed conversion to general anesthesia
- timeFrame
- Intraoperative
- description
- Percentage of patients who needed conversion to general anesthesia. A percentage from 0 to 100%, where 0% means that no patient needs technique conversion to general anesthesia and 100% means that all patients need it.
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Undergo axillary dissection due to metastatic skin or soft tissue cancer; * ASA physical status classification between I and III; * have signed the informed consent. Exclusion Criteria: * weight less than 40 kilograms; * tumor affecting topography to be blocked; * presence of ulcerated lesion in the axilla; * presence of coagulopathy.
References
Publications (18)
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- BACKGROUNDStoffels I, Dissemond J, Korber A, Hillen U, Poeppel T, Schadendorf D, Klode J. Reliability and cost-effectiveness of sentinel lymph node excision under local anaesthesia versus general anaesthesia for malignant melanoma: a retrospective analysis in 300 patients with malignant melanoma AJCC Stages I and II. J Eur Acad Dermatol Venereol. 2011 Mar;25(3):306-10. doi: 10.1111/j.1468-3083.2010.03786.x. PMID 20626530
- BACKGROUNDStoffels I, Dissemond J, Schulz A, Hillen U, Schadendorf D, Klode J. Reliability and cost-effectiveness of complete lymph node dissection under tumescent local anaesthesia vs. general anaesthesia: a retrospective analysis in patients with malignant melanoma AJCC stage III. J Eur Acad Dermatol Venereol. 2012 Feb;26(2):200-6. doi: 10.1111/j.1468-3083.2011.04036.x. Epub 2011 Mar 17. PMID 21414036
- BACKGROUNDPawa A, Wight J, Onwochei DN, Vargulescu R, Reed I, Chrisman L, Pushpanathan E, Kothari A, El-Boghdadly K. Combined thoracic paravertebral and pectoral nerve blocks for breast surgery under sedation: a prospective observational case series. Anaesthesia. 2018 Apr;73(4):438-443. doi: 10.1111/anae.14213. Epub 2018 Jan 12. PMID 29327341
- BACKGROUNDWoodworth GE, Ivie RMJ, Nelson SM, Walker CM, Maniker RB. Perioperative Breast Analgesia: A Qualitative Review of Anatomy and Regional Techniques. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):609-631. doi: 10.1097/AAP.0000000000000641.