Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ultrasound-guided Deep and Superficial Serratus Anterior Plane Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252378
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Saeyoung Kim, MD, PhD, Kyungpook National University Hospital

Brief Summary:
This study evaluates the difference of deep and superficial serratus anterior plane block on intraoperative opioid consumption, emergence time and hemodynamic stability in patients undergoing video-assisted thoracic surgery.

Condition or disease Intervention/treatment Phase
Pain Management Thoracotomy Procedure: Deep Serratus Anterior Plane Block Procedure: Superficial Serratus Anterior Plane Block Not Applicable

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. Two methods were proposed to target the top and bottom of the serratus anterior muscle. However, the difference of deep and superficial serratus anterior plane block during intraoperative period has not yet been studied.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Intraoperative Opioid Consumption, Emergence Time and Hemodynamic Stability Between Ultrasound-guided Deep and Superficial Serratus Anterior Plane Block During Video-assisted Thoracoscopic Lobectomy
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Deep Serratus Anterior Plane Block
Deep Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance. 20ml of 0.375% ropivacaine was slowly injected between the fascia of serratus anterior and external intercostal muscle near 5th rib.
Procedure: Deep Serratus Anterior Plane Block
Deep Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance.

Active Comparator: Superficial Serratus Anterior Plane Block
Superficial Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance. 20ml of 0.375% ropivacaine was slowly injected between the fascia of serratus anterior and latissimus dorsi near 5th rib.
Procedure: Superficial Serratus Anterior Plane Block
Superficial Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance.




Primary Outcome Measures :
  1. Intraoperative remifentanil consumption [ Time Frame: through study completion, an average of 1 year ]
    Intraoperative remifentanil consumption will be checked.


Secondary Outcome Measures :
  1. 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.

  2. Systolic blood pressure [ Time Frame: through study completion, an average of 1 year ]
    Systolic blood pressure (mmHg) will be checked

  3. Heart rate (HR) Heart rate [ Time Frame: through study completion, an average of 1 year ]
    Heart rate (beats per minute) will be checked

  4. 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

  5. Postoperative pain: numeric rating scale [ Time Frame: 30 minutes later operation ]
    Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a) American Society of Anesthesiologists (ASA) physical status 1 or 2
  • b) age 20-75 years
  • c) elective three port Video-assisted thoracoscopic surgery (VATS) lobectomy.

Exclusion Criteria:

  • a) a history of drug allergy for opioids or local anesthetics
  • b) local infection at the injection site and systemic infection
  • c) coagulopathy
  • d) difficulty in understanding the study protocol
  • e) refusal to participate

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): NCT04252378


Contacts
Layout table for location contacts
Contact: Jimin Heo +82-53-420-5430 knuhmrc@knu.ac.kr
Contact: Saeyoung Kim +82-53-420-5873 saeyoungkim7@gmail.com

Locations
Layout table for location information
Korea, Republic of
Kyungpook national university hospital Recruiting
Daegu, Korea, Republic of, 700-412
Contact: Jimin Heo    82-53-420-5430    knuhmrc@knu.ac.kr   
Sponsors and Collaborators
Kyungpook National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Saeyoung Kim Kyungpook National University Hospital
Layout table for additonal information
Responsible Party: Saeyoung Kim, MD, PhD, Associate professor, Kyungpook National University Hospital
ClinicalTrials.gov Identifier: NCT04252378    
Other Study ID Numbers: 2019-05-003-001
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No