The Effects of Ultrasound-guided Serratus Plane Block During Video-assisted Thoracoscopic Lobectomy

February 26, 2019 updated by: Saeyoung Kim, MD, PhD, Kyungpook National University Hospital

The Effects of Ultrasound-guided Serratus Plane Block in Combination With General Anesthesia on Intraoperative Opioid Consumption, Emergence Time and Hemodynamic Stability During Video-assisted Thoracoscopic Lobectomy

This study evaluates the effects of serratus plane block on intraoperative opioid consumption, emergence time and hemodynamic stability in patients undergoing video-assisted thoracic surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Thoracotomy is known as one of the most painful surgery. Thus, there is a development to reduce surgical stress in terms of operation technique, which is video-assisted thoracoscopic surgery. Although it has reduced postoperative pain and complications compared with thoracotomy, VATS is still quite painful operation.

Serratus plane block is a novel technique which provide analgesic effect for lateral chest wall by blocking lateral branch of intercostal nerve. It has been reported to be used for pain management including rib fracture, herpes zoster, and postoperative pain. It has become a popular analgesic modality because it is easy to perform and relatively safe. However, the effect of serratus plane block during intraoperative period has not yet been studied.

In this study, therefore, the investigators decided to assess the effect of serratus plane block on intraoperative opioid consumption, emergence time and hemodynamic stability in patients undergoing video-assisted thoracic surgery.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

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

  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-412
        • Recruiting
        • Kyungpook National University 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

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists physical status classification I-III for three port video-assisted thoracic surgery lobectomy under general anesthesia

Exclusion Criteria:

  • History of allergic reaction to local anesthetics, coagulopathy, local infection at the injection site, and systemic infection.

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Serratus plane block
The subjects were received serratus plane block in the regional-anesthesia unit out of operation room before induction of general anesthesia. And, video-assisted thoracic surgery was performed under balanced general anesthesia.
Procedure: Serratus plane block
The subjects were received serratus plane block in the regional-anesthesia unit out of operation room before induction of general anesthesia. And, video-assisted thoracic surgery was performed under balanced general anesthesia.
ACTIVE_COMPARATOR: General anesthesia only
Video-assisted thoracic surgery was performed under balanced general anesthesia without serratus plane block
Procedure: General anesthesia only
Video-assisted thoracic surgery was performed under balanced general anesthesia without serratus plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative remifentanil consumption
Time Frame: through study completion, an average of 1 year
Intraoperative remifentanil consumption will be checked.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergence time
Time Frame: through study completion, an average of 1 year
Emergence time is duration between the end of surgery and extubation. Emergence time will be checked.
through study completion, an average of 1 year
Systolic blood pressure
Time Frame: through study completion, an average of 1 year
Systolic blood pressure (mmHg) will be checked
through study completion, an average of 1 year
Dose of rescue drugs used to control blood pressure and HR
Time Frame: through study completion, an average of 1 year
Dose of rescue drugs used to control blood pressure and HR will be checked
through study completion, an average of 1 year
Heart rate
Time Frame: through study completion, an average of 1 year
Heart rate (beats per minute) will be checked
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Kyungpook National University 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)

August 28, 2018

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

June 1, 2019

Study Registration Dates

First Submitted

October 18, 2018

First Submitted That Met QC Criteria

October 22, 2018

First Posted (ACTUAL)

October 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-06-006-002

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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