Ultrasound-guided Deep and Superficial Serratus Anterior Plane Block

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain Management; Thoracotomy
• Intervention / Treatment: Procedure: Deep Serratus Anterior Plane Block; Procedure: Superficial Serratus Anterior Plane Block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saeyoung Kim; Phone Number: +82-53-420-5873; Email: saeyoungkim7@gmail.com

Study Locations

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

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative remifentanil consumption	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	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	Systolic blood pressure (mmHg) will be checked	through study completion, an average of 1 year
Heart rate (HR) Heart rate	Heart rate (beats per minute) will be checked	through study completion, an average of 1 year
Dose of rescue drugs used to control blood pressure and HR	Dose of rescue drugs used to control blood pressure and HR will be checked	through study completion, an average of 1 year
Postoperative pain: numeric rating scale	Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)	30 minutes later operation

Collaborators and Investigators

• Sponsor: Kyungpook National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2019
• Primary Completion (ANTICIPATED): February 29, 2020
• Study Completion (ANTICIPATED): March 31, 2020

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (ACTUAL): February 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 1, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2019-05-003-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No