Thoracic Combined Spinal Epidural Anesthesia for Breast Surgery

May 17, 2021 updated by: Antalya Training and Research Hospital

Segmental High Thoracic Combined Spinal Epidural Anesthesia for Breast Surgery

The aim of the study is to investigate the efficacy of the thoracic combined spinal epidural anesthesia in breast surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Previous studies of the regional anesthetic techniques such as erector spinae plane block and pectoralis nerve blocks (PECs blocks) additional to general anesthesia have described their use for postoperative analgesia in breast surgery. It has been also reported that these blocks can be used to provide surgical anesthesia in breast surgery . Segmental thoracic epidural anesthesia can be used as an alternative anesthetic technique in patients with severe chronic obstructive pulmonary disease and asthma undergoing breast surgery. It has been also reported that thoracic spinal anesthesia was effective and successful in patients undergoing laparoscopic surgery. In this study, efficacy of high thoracic spinal epidural anesthesia in patients undergoing breast surgery will be evaluated.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey
        • Antalya Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Adults between 18-75 years of age and who will be to undergo elective breast surgery

Description

Inclusion Criteria:

  • Patients who will be to undergo elective surgery for breast surgery
  • American Society of Anesthesiologists (ASA) physical status classification groups I or II

Exclusion Criteria:

  • body mass index>35 kg/m2,
  • presence of any condition complicating and contraindicating spinal epidural anesthesia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Block success
Time Frame: through study completion, an average of 3 months
the number of patients whose surgery was completed without general anesthesia
through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Training and Research Hospital

Investigators

  • Study Director: Lutfi Ozyurek, M.D., Antalya Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 4, 2021

Primary Completion (ACTUAL)

April 13, 2021

Study Completion (ACTUAL)

May 17, 2021

Study Registration Dates

First Submitted

January 10, 2021

First Submitted That Met QC Criteria

January 10, 2021

First Posted (ACTUAL)

January 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lutfi1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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