NCT03718377

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

October 18, 2018

Last Update Submit

February 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intraoperative remifentanil consumption

    Intraoperative remifentanil consumption will be checked.

    through study completion, an average of 1 year

Secondary Outcomes (4)

  • Emergence time

    through study completion, an average of 1 year

  • Systolic blood pressure

    through study completion, an average of 1 year

  • Heart rate

    through study completion, an average of 1 year

  • Dose of rescue drugs used to control blood pressure and HR

    through study completion, an average of 1 year

Study Arms (2)

Serratus plane block

EXPERIMENTAL

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

General anesthesia only

ACTIVE COMPARATOR

Video-assisted thoracic surgery was performed under balanced general anesthesia without serratus plane block

Procedure: General anesthesia only

Interventions

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.

Serratus plane block

Video-assisted thoracic surgery was performed under balanced general anesthesia without serratus plane block

General anesthesia only

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook national university hospital

Daegu, 700-412, South Korea

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Saeyoung Kim

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 18, 2018

First Posted

October 24, 2018

Study Start

August 28, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations