VATS Block for Uniportal Video-assisted Thoracoscopic Surgery

Not Applicable

• Conditions: Efficacy and Safety of VATS Block
• Interventions: Procedure: VATS; Drug: Ropivacaine; Drug: Epinephrine

• Registration Number: NCT03083080
• Lead Sponsor: Taipei Medical University WanFang Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-03-12
• Study First Posted: 2017-03-17
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-22
• Study Start: 2017-03-27
• Primary Completion: 2019-03-26
• Study Completion: 2019-03-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VATS block (ropivacaine + epinephrine)	VATS	VATS block is the peripheral nerve block for video-assisted thoracic surgery, whose injection is administered at the site of chest wall incision.
VATS block (ropivacaine + epinephrine)	Ropivacaine	VATS block is the peripheral nerve block for video-assisted thoracic surgery, whose injection is administered at the site of chest wall incision.
VATS block (ropivacaine + epinephrine)	Epinephrine	VATS block is the peripheral nerve block for video-assisted thoracic surgery, whose injection is administered at the site of chest wall incision.

Primary Outcome Measures

Name	Time	Method
Numerical rating scale intraoperatively	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	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)

Secondary Outcome Measures

Name	Time	Method
Common characteristics of ultrasound anatomy by analyzing video clips	Three time points (upon obtaining informed consent, prior to injection and during injection)	Recording the ultrasound images at three time points
Ropivacaine concentration at different time points after injection	Up to 120 mins following injection	Blood sampling at seven time points (10, 20, 30, 45, 60, 90, 120 minutes following injection)
Numerical rating scale postoperatively	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)