VATS Block for Uniportal Video-assisted Thoracoscopic Surgery

March 20, 2017 updated by: Taipei Medical University WanFang Hospital

Ultrasound-guided Peripheral Nerve Block for Non-intubated Uniportal Video-assisted Thoracoscopic Surgery

Traditionally, video-assisted thoracic surgery is performed under general anesthesia with double-lumen endotracheal tube. However, the complications associated with this large tube as well as inhalation anesthetics are frequently reported. Therefore, currently there is a trend toward non-intubated anesthesia methods for video-assisted thoracic surgery, which includes thoracic epidural block, peripheral nerve block, local anesthesia, local combined with peripheral nerve block, etc. Thoracic epidural block demands a high technique, but still risks catastrophic neurological complications in case of accidental dural puncture. Local anesthesia, perhaps more straightforward, however may need supplemental analgesia during incision, which will inevitably interrupt surgery and negatively affect the patients. This study aims to apply ultrasound guidance during local anesthetic injection for local anesthesia-based video assisted thoracic surgery, which helps inject the local anesthetic into the key intercostal nerve plane to provide more specific and precise blockade, thus avoiding the chance of blind injection. At the same time, ultrasound guidance has the potential to reduce the risk of systemic toxicity, prolong the duration of analgesia postoperatively, and facilitates postoperative recovery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults younger than 80 years old and weighing between 50-90 kg are scheduled for one-port video assisted thoracic surgery .

Exclusion Criteria:

  • Anticipated difficult airway
  • Obvious coagulation abnormality
  • Psychiatric patients or drug addiction
  • Emergency operation or patients with a full stomach
  • Difficulty in language expression
  • Allergic to local anesthetic, morphine, or NSAID
  • BMI > 35
  • Pregnancy
  • Respiratory insufficiency
  • Severe pleural adhesion
  • Need for pleurodesis
  • Refuse patient-controlled analgesia
  • Patients with a pacemaker
  • Severe liver dysfunction (serum albumin<25g/l or Child-Pugh score≧10)
  • Severe kidney dysfunction (creatinine clearance<30ml/min)
  • Inflammatory bowel disease
  • Congestive heart failure (NYHA II-IV)
  • Confirmed ischemic heart disease, peripheral arterial disease and/or cerebral vascular disease
  • Patients with a high intra-ocular pressure (e.g. glaucoma)
  • Neurological symptoms over the ipsilateral upper part of the body

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VATS block (ropivacaine + epinephrine)
VATS block is the peripheral nerve block for video-assisted thoracic surgery, whose injection is administered at the site of chest wall incision.
Procedure: VATS
VATS is the abbreviation of video-assisted thoracic surgery, which aims to minimize the wound for thoracic surgery and to enhance patient recovery after surgery
Drug: Ropivacaine
30 mL 0.5% ropivacaine is used to achieve VATS block
Drug: Epinephrine
1:400000 epinephrine is mixed with ropivacaine (local anesthetic) to reduce the risk of local anesthetic systemic toxicity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numerical rating scale intraoperatively
Time Frame: During chest wall incision
Self-reporting pain intensity, pain site, and analgesic dosage during surgery
During chest wall incision
TIme to lose skin sensation (light touch and thermal) over the injection site
Time Frame: Up to 30 mins after ropivacaine injection
Skin sensation will be tested every 5 minutes after ropivacaine injection until loss of both sensation (readiness for skin incision)
Up to 30 mins after ropivacaine injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ropivacaine concentration at different time points after injection
Time Frame: Up to 120 mins following injection
Blood sampling at seven time points (10, 20, 30, 45, 60, 90, 120 minutes following injection)
Up to 120 mins following injection
Common characteristics of ultrasound anatomy by analyzing video clips
Time Frame: Three time points (upon obtaining informed consent, prior to injection and during injection)
Recording the ultrasound images at three time points
Three time points (upon obtaining informed consent, prior to injection and during injection)
Numerical rating scale postoperatively
Time Frame: Up to 72 hours following surgery
Pain scores evaluated at six time points (at the conclusion of surgery, and at 2h, 6h, 24h, 48h, and 72h post-surgery)
Up to 72 hours following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical University WanFang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 26, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201504056

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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