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

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: Pain Management; Anesthesia, Conduction
• Intervention / Treatment: Procedure: Serratus plane block; Procedure: General anesthesia only

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

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:

• 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

How is the study designed?

Design Details

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

Number of Arms

2

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	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
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
Heart rate	Heart rate (beats per minute) will be checked	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Kyungpook National University Hospital

Study record dates

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: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• 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