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Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection

NCT03740815 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-04-08

No results posted yet for this study

Summary

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

  • Anesthesia
  • Regional Anesthesia Morbidity
  • Axillary Metastases
  • Nerve Block
  • Analgesia
  • Skin Cancer

Interventions

PROCEDURE

Serratus plane block

Ultrasound guided injection of local anesthetic between latissimus dorsi and serratus muscles at mid axillary line.

PROCEDURE

Axillary dissection

Axillary dissection is a surgical procedure that incises the axilla to identify, examine, or remove lymph nodes.

PROCEDURE

Intravenous sedation

Administration of sedatives thru an intravenous access to achieve relaxion and improve operative conditions.

Sponsors & Collaborators

  • Instituto Nacional de Cancer, Brazil

    lead OTHER_GOV

Principal Investigators

  • Daniele Theobald, MD · National Cancer Institute of Brazil (INCA - Brazil)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-25
Primary Completion
2021-03-02
Completion
2021-03-02

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03740815 on ClinicalTrials.gov