ClinicalTrials.gg
Status unknownNCT03718377Updated Feb 27, 2019

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

An interventional study of Serratus plane block and General anesthesia only in Anesthesia, Conduction and Pain Management, sponsored by Kyungpook National University Hospital. Status unknown at 1 site in South Korea. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-02-27.

Sponsored by Kyungpook National University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anesthesia, Conduction
  • Pain Management
03

In context

Lead sponsor

Kyungpook National University Hospital is the lead sponsor of 80 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • History of allergic reaction to local anesthetics, coagulopathy, local infection at the injection site, and systemic infection.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • Active comparator
    General anesthesia only

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

    Procedure: General anesthesia only

Interventions

  • ProcedureSerratus 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.

  • ProcedureGeneral anesthesia only

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

06

What researchers measure

Primary outcomes

  1. Intraoperative remifentanil consumption

    Intraoperative remifentanil consumption will be checked.

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Emergence time

    Emergence time is duration between the end of surgery and extubation. Emergence time will be checked.

    Time frame: through study completion, an average of 1 year

  2. Systolic blood pressure

    Systolic blood pressure (mmHg) will be checked

    Time frame: through study completion, an average of 1 year

  3. Heart rate

    Heart rate (beats per minute) will be checked

    Time frame: through study completion, an average of 1 year

  4. 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

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • Kyungpook national university hospital
    Daegu, 700-412, South Korea
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2018 (actual). Primary completion is estimated for Jun 2019, 10 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2018
First posted
Oct 24, 2018
StartActual
Aug 28, 2018
Primary completionEst.
Jun 2019
CompletionEst.
Jun 2019
Last update
Feb 27, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03718377
Lead sponsor
Kyungpook National University Hospital
Responsible party
Saeyoung Kim, MD, PhD (Associate professor, Kyungpook National University Hospital) — Principal investigator
First posted
Oct 24, 2018
Start date
Aug 28, 2018
Primary completion
Jun 2019 (estimated)
Completion
Jun 2019 (estimated)
Last update
Feb 27, 2019

Study contacts

Jimin Heo
Contact
knuhmrc@knu.ac.kr
82-53-420-5430
Saeyoung Kim
principal investigator · Kyungpook National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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