VATS Block for Uniportal Video-assisted Thoracoscopic Surgery

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: Unknown
• Conditions: Efficacy and Safety of VATS Block
• Intervention / Treatment: Procedure: VATS; Drug: Ropivacaine; Drug: Epinephrine

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jui-An Lin; Phone Number: 2160 +886-2-29307930; Email: juian.lin@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Numerical rating scale intraoperatively	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	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

Outcome Measure	Measure Description	Time Frame
Ropivacaine concentration at different time points after 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	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	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

• Sponsor: Taipei Medical University WanFang Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 27, 2017
• Primary Completion (Anticipated): March 26, 2019
• Study Completion (Anticipated): March 26, 2019

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: March 12, 2017
• First Posted (Actual): March 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Ropivacaine; Epinephrine
• Other Study ID 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