Efficacy and Safety of VATS BlockNCT03083080
VATS Block for Uniportal Video-assisted Thoracoscopic Surgery
A study testing VATS, Ropivacaine and Epinephrine in people with Efficacy and Safety of VATS Block, run by Taipei Medical University WanFang Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Efficacy and Safety of VATS Block
- What is being tested?
- VATS, Ropivacaine and Epinephrine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 27 Mar 2017to 26 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults younger than 80 years old and weighing between 50-90 kg are scheduled for one-port video assisted thoracic surgery .
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Efficacy and Safety of VATS Block
- Being tested
- VATS, Ropivacaine, Epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATSProcedure or surgery
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
RopivacaineDrug
30 mL 0.5% ropivacaine is used to achieve VATS block
EpinephrineDrug
1:400000 epinephrine is mixed with ropivacaine (local anesthetic) to reduce the risk of local anesthetic systemic toxicity
| Study group | Role | What they receive |
|---|---|---|
| VATS block (ropivacaine + epinephrine) | Experimental | VATS block is the peripheral nerve block for video-assisted thoracic surgery, whose injection is administered at the site of chest wall incision. Receives: Procedure: VATS; Drug: Ropivacaine; Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale intraoperatively
Self-reporting pain intensity, pain site, and analgesic dosage during surgery
Measured: During chest wall incision
TIme to lose skin sensation (light touch and thermal) over the injection site
Skin sensation will be tested every 5 minutes after ropivacaine injection until loss of both sensation (readiness for skin incision)
Measured: Up to 30 mins after ropivacaine injection
Secondary outcomes (3)
Ropivacaine concentration at different time points after injection
Blood sampling at seven time points (10, 20, 30, 45, 60, 90, 120 minutes following injection)
Measured: Up to 120 mins following injection
Common characteristics of ultrasound anatomy by analyzing video clips
Recording the ultrasound images at three time points
Measured: Three time points (upon obtaining informed consent, prior to injection and during injection)
Numerical rating scale postoperatively
Pain scores evaluated at six time points (at the conclusion of surgery, and at 2h, 6h, 24h, 48h, and 72h post-surgery)
Measured: Up to 72 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start27 Mar 2017 (estimated)
- Primary completion26 Mar 2019 (estimated)
- Study completion26 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy and Safety of VATS BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083080
- Sponsor's protocol ID
- 201504056
- Status last verified
- Feb 2017
- First submitted
- 20 Feb 2017
- Last updated
- 22 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Peripheral Nerve Block for Non-intubated Uniportal Video-assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT03083080
- Acronym / sponsor ID
- 201504056
- Conditions
- Efficacy and Safety of VATS Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 27 Mar 2017 (estimated)
- Primary completion
- 26 Mar 2019 (estimated)
- Study completion
- 26 Mar 2019 (estimated)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VATS block (ropivacaine + epinephrine) | Experimental | Procedure: VATS, Drug: Ropivacaine, Drug: EpinephrineVATS block is the peripheral nerve block for video-assisted thoracic surgery, whose injection is administered at the site of chest wall incision. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults younger than 80 years old and weighing between 50-90 kg are scheduled for one-port video assisted thoracic surgery .
Key exclusion criteria (20 listed)
- Anticipated difficult airway
- Obvious coagulation abnormality
- Psychiatric patients or drug addiction
- Emergency operation or patients with a full stomach
- Difficulty in language expression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VATSVATS is the abbreviation of video-assisted thoracic surgery, which aims to minimize the wound for thoracic surgery and to enhance patient recovery after surgery | Procedure or surgery | VATS block (ropivacaine + epinephrine) |
| Ropivacaine30 mL 0.5% ropivacaine is used to achieve VATS block | Drug | VATS block (ropivacaine + epinephrine) |
| Epinephrine1:400000 epinephrine is mixed with ropivacaine (local anesthetic) to reduce the risk of local anesthetic systemic toxicity | Drug | VATS block (ropivacaine + epinephrine) |
Primary outcome
Numerical rating scale intraoperatively
Time frame: During chest wall incision
Self-reporting pain intensity, pain site, and analgesic dosage during surgery
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)
3 secondary outcomes
Ropivacaine concentration at different time points after injection
Time frame: 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)
Numerical rating scale postoperatively
Time frame: Up to 72 hours following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
Related trials for Efficacy and Safety of VATS Block
Recruiting
The Efficacy and Safety of Liposomal Bupivacaine for Rhomboid Intercostal Nerve Block in Relieving Postoperative Pain After Video-assisted Thoracoscopic Surgery
Video-assisted Thoracoscopic Surgery (VATS), Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing VATS, Ropivacaine and Epinephrine in people with Efficacy and Safety of VATS Block, run by Taipei Medical University WanFang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jui-An Lin (+886-2-29307930 ext. 2160, juian.lin@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale intraoperatively (time frame: During chest wall incision). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.