NCT04252378

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.

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
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

January 31, 2020

Last Update Submit

February 1, 2020

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 (5)

  • Emergence time

    through study completion, an average of 1 year

  • Systolic blood pressure

    through study completion, an average of 1 year

  • Heart rate (HR) 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

  • Postoperative pain: numeric rating scale

    30 minutes later operation

Study Arms (2)

Deep Serratus Anterior Plane Block

EXPERIMENTAL

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

Superficial Serratus Anterior Plane Block

ACTIVE COMPARATOR

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

Interventions

Deep Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance.

Deep Serratus Anterior Plane Block

Superficial Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance.

Superficial Serratus Anterior Plane Block

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

July 15, 2019

Primary Completion

February 29, 2020

Study Completion

March 31, 2020

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations