CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Serratus plane block +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03740815
NCT03740815N/ACompleted

Assessment of the Feasibility of Ultrasound Guided Serratus Plane Block Associated With Sedation as Anesthetic Technique in Axillary Dissection

Instituto Nacional de Cancer, Brazil·interventional·Posted Nov 14, 2018·Updated Apr 8, 2022

In Brief

A clinical study evaluating Serratus plane block, Axillary dissection, and 1 other intervention for Anesthesia and 5 related conditions. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 14, 2018
Enrollment StartSep 25, 2018
Primary CompletionMar 2, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.6 years ago

Interventions

Serratus plane blockprocedure

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

Axillary dissectionprocedure

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

Intravenous sedationprocedure

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