Clinical trial · Interventional
Comparative Analysis of Three Locoregional Anesthesia Methods in Breast Tumour Pathology Surgery
- 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)
The present study compares the Erector Spinae Plane (ESP) block, Pectoral (PECS II) block, and Serratus-Intercostal Fascial Plane (SIFP) block. This is the first article to compare these three locoregional nerve block techniques in acute and chronic postoperative pain in breast tumour surgery. From June 1, 2018, to June 30, 2019, 103 patients undergoing breast cancer surgery were randomised to undergo one of three locoregional techniques (35 for ESP block, 34 for PECS II block, 34 for SIFP block). Locoregional techniques were performed under light sedation and then, general anaesthesia was used for the breast cancer surgery. Outcomes measured included pain (visual analog scale \[VAS\] in immediate postoperatory and at 24 hours. It also was collected opioid use at 24 hours, adverse events, and length of stay (for acute postoperatory). Moreover, at 3 months, a telephone interview was conducted with the patient and VAS was questioned. A year later, the patient was questioned again and asked for VAS, location of her pain, and pharmacological treatment. It was collected if patients were assisted or not by a Pain Unit.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Pain | — | UNRESOLVED | — |
| Breast Tumor | Breast Neoplasm | ALIAS | 0.90 |
| Chronic Post Operative Pain | — | UNRESOLVED | — |
| Locoregional Anesthesia | — | UNRESOLVED | — |
| Postoperative Pain | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ESP block: Locoregional Interfascial Anesthesic Technique | Procedure | — | UNRESOLVED |
| PECS II block: Locoregional Interfascial Anesthesic Technique | Procedure | — | UNRESOLVED |
| SIFP Block Locoregional Interfascial Anesthesic Technique | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Erector Spinae Plane Block (ESP block)
- description
- The patient is positioned in the prone position, the probe is used to locate in cross-section the T4 spinous process. Next, using a lateral scan, approximately 3 cm away, the costotransverse joint is located, and then change to sagittal ultrasound vision. By locating the intertransverse line with the probe, the following anatomical structures can be identified: three longitudinal muscles (trapezius, rhomboid, erector spinae). The needle enters in a single punction at an angle of 45º, in the cranio-caudal direction, until it touches the apex of the costotransverse image. Subsequently, 30 cc of 0.25% bupivacaine are administered in the depth of the erector spinae, which will remain elevated.
- interventionNames
- Procedure: ESP block: Locoregional Interfascial Anesthesic Technique
- type
- ACTIVE_COMPARATOR
- label
- Pectoral Nerve type II Block (PECS II block)
- description
- The patient is positioned supine, with the ipsilateral upper limb extended. The clavicular external third line is drawn. In parallel, the lower costal line and the infraclavicular space are highlighted. The probe obtains an image that allows the identification of the pectoralis major and pectoralis minor. If colour Doppler is added, the acromiothoracic artery is identified and must be avoided. The needle enters at an angle of 45º from medial to lateral, and 20 cc of 0.25% bupivacaine are administered. Next, needle advances in the interfascial space between the pectoral minor and serratus anterior and 10 cc of 0.25% bupivacaine are administered.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Female patient undergoing elective surgery for breast tumour pathology. Exclusion Criteria: * Previous breast tumour pathology surgery. * Breast prosthesis carrier. * Coagulopathy. * Pregnancy or lactation. * Puncture site infection. * Chest wall deformity. * Hemodynamically unstable patient. * Refusal of the patient to undergo locoregional technique. * The patient refuses to take part in the study or revocation of the Informed Consent.
References
Publications (0)
Data not yet available