Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection

NCT03740815 | Completed

• 1 other identifier: CAAE 89037818.0.0000.5274
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who needed conversion to general anesthesia

  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.

  Intraoperative

Secondary Outcomes (7)

• The 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire.

  Preoperative and in Postoperative day 30

• QoR-40 questionnaire

  Preoperative, First postoperative day visit and in Postoperative day 30

• Surgeon satisfaction - 5 points Likert scale

  Imediate postoperative period

• Patient satisfaction - 5 points Likert scale

  First postoperative day visit

• Numeric pain rating scale (0-10)

  Preoperative, postoperative day 1 and 30

Study Arms (1)

Serratus plane block plus sedation

EXPERIMENTAL

Serratus plane block plus intravenous sedation as anesthetic technique during axillary dissection procedure.

Procedure: Serratus plane block; Procedure: Axillary dissection; Procedure: Intravenous sedation

Interventions

Serratus plane block PROCEDURE

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

Serratus plane block plus sedation

Axillary dissection PROCEDURE

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

Also known as: Axillary limphadenectomy

Serratus plane block plus sedation

Intravenous sedation PROCEDURE

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

Also known as: Sedation

Serratus plane block plus sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergo axillary dissection due to metastatic skin or soft tissue cancer;
• ASA physical status classification between I and III;
• have signed the informed consent.

You may not qualify if:

• weight less than 40 kilograms;
• tumor affecting topography to be blocked;
• presence of ulcerated lesion in the axilla;
• presence of coagulopathy.

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

Hospital do Câncer II - National Cancer Institute of Brazil (INCA - Brazil)

Rio de Janeiro, Rio de Janeiro/RJ, 20220-410, Brazil

Location

Related Publications (18)

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Related Links

• EORTC QLQ-C30 Scoring Manual. 2001 EORTC, Brussels. ISBN 2-9300 64-22-6.

MeSH Terms

Conditions

Agnosia; Skin Neoplasms

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Daniele Theobald, MD

  National Cancer Institute of Brazil (INCA - Brazil)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: November 14, 2018
• Study Start: September 25, 2018
• Primary Completion: March 2, 2021
• Study Completion: March 2, 2021
• Last Updated: April 8, 2022

Record last verified: 2021-08

Locations

BR (1)