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Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection

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ClinicalTrials.gov Identifier: NCT03740815
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Instituto Nacional de Cancer, Brazil

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.


Condition or disease Intervention/treatment Phase
Anesthesia Regional Anesthesia Morbidity Axillary Metastases Nerve Block Analgesia Skin Cancer Procedure: Serratus plane block Procedure: Axillary dissection Procedure: Intravenous sedation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Feasibility of Ultrasound Guided Serratus Plane Block Associated With Sedation as Anesthetic Technique in Axillary Dissection
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Serratus plane block plus sedation
Serratus plane block plus intravenous sedation as anesthetic technique during axillary dissection procedure.
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.
Other Name: Axillary limphadenectomy

Procedure: Intravenous sedation
Administration of sedatives thru an intravenous access to achieve relaxion and improve operative conditions.
Other Name: Sedation




Primary Outcome Measures :
  1. Percentage of patients who needed conversion to general anesthesia [ Time Frame: Intraoperative ]
    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 Outcome Measures :
  1. The 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire. [ Time Frame: Preoperative and in Postoperative day 30 ]

    The QLQ-C30 is composed of multi-item scales and single-item measures. These include:

    • A global health status / QoL scale
    • Five functional scales (Physical functioning, Role functioning, Emotional functioning, Cognitive functioning, Social functioning)
    • Three symptom scales (Fatigue, Nausea and vomiting, Pain)
    • Six single items (Dyspnoea, Insomnia, Appetite loss, Constipation, Diarrhoea, Financial difficulties) Each of the multi-item scales includes a different set of items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems . The scales are scored as described as described in EORTC QLQ-C30 Scoring Manual. 2001 EORTC, Brussels.

  2. QoR-40 questionnaire [ Time Frame: Preoperative, First postoperative day visit and in Postoperative day 30 ]

    Quality of Recovery - 40 Item questionnaire

    QoR-40 score is a score developed to estimate the quality of recovery after anesthesia. It consists of a 40-item questionnaire with items on a five- point Likert scale (for positive items, 1 'none of the time' to 5 'all of the time'; for negative items the scoring was reversed). It is scored as follows:

    QoR-40 dimensions

    • Emotional state (9-45)
    • Physical comfort (12-60)
    • Psychological support (7-35)
    • Physical independence (5-25)
    • Pain (7-35) Global QoR-40 (40-200)

  3. Surgeon satisfaction - 5 points Likert scale [ Time Frame: Imediate postoperative period ]

    A five points Likert scale will be applied to the main surgeon responsible for the operation.

    The surgeon will be asked to fill out a Likert 5 points scale to access his opinion about the quality of anesthesia (extremely satisfied, satisfied, not satisfied or dissatisfied, dissatisfied, extremely dissatisfied).


  4. Patient satisfaction - 5 points Likert scale [ Time Frame: First postoperative day visit ]
    A five points Likert scale will be applied to the patient in the first postoperative day visit to access his opinion about the quality of the anesthesia (extremely satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, extremely dissatisfied).

  5. Numeric pain rating scale (0-10) [ Time Frame: Preoperative, postoperative day 1 and 30 ]
    Eleven point numeric pain rating scale (0 means no pain and 10 means worst possible pain).

  6. Analgesic requirement [ Time Frame: Intraoperative and postoperative day one (cumulative dose) ]
    All the anesthetics and analgesics used in intraoperative and postoperative period will be recorded. Doses will be recorded in database.

  7. Number of lymph nodes extracted [ Time Frame: Postoperative day 30 (according to anatomopathological report) ]
    Number of lymph nodes extracted according to anatomopathological report.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740815


Contacts
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Contact: Daniele Theobald, MD 00552132072915 danieletheobald@yahoo.com.br
Contact: Bruno LC Araujo, MD 005521988400944 brunoaraujomed@yahoo.com.br

Locations
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Brazil
Hospital do Câncer II - National Cancer Institute of Brazil (INCA - Brazil) Recruiting
Rio de Janeiro, Rio De Janeiro/RJ, Brazil, 20220-410
Contact: Daniele Theobald, MD    00552132072915    danieletheaobald@yahoo.com.br   
Contact: Bruno LC Araujo, MD    005521988400944    brunoaraujomed@yahoo.com.br   
Principal Investigator: Daniele Theobald, MD         
Sponsors and Collaborators
Instituto Nacional de Cancer, Brazil
Investigators
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Principal Investigator: Daniele Theobald, MD National Cancer Institute of Brazil (INCA - Brazil)

Publications:

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Responsible Party: Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier: NCT03740815     History of Changes
Other Study ID Numbers: CAAE 89037818.0.0000.5274
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs