Clinical trial NCT03083080: VATS Block for Uniportal Video-assisted Thoracoscopic Surgery
Official title: Ultrasound-guided Peripheral Nerve Block for Non-intubated Uniportal Video-assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Efficacy and Safety of VATS Block
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Numerical rating scale intraoperatively
timeFrame: During chest wall incision
measure: TIme to lose skin sensation (light touch and thermal) over the injection site
timeFrame: Up to 30 mins after ropivacaine injection
Secondary outcomes:
measure: Ropivacaine concentration at different time points after injection
timeFrame: Up to 120 mins following injection
measure: Common characteristics of ultrasound anatomy by analyzing video clips
timeFrame: Three time points (upon obtaining informed consent, prior to injection and during injection)
measure: Numerical rating scale postoperatively
timeFrame: Up to 72 hours following surgery
Other outcomes:
Locations:
Study officials:
References: