VATS Block for Uniportal Video-assisted Thoracoscopic Surgery

NCT03083080 | Unknown

• 1 other identifier: 201504056
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Efficacy and Safety of VATS Block

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Ropivacaine concentration at different time points after injection

  Up to 120 mins following injection

• Common characteristics of ultrasound anatomy by analyzing video clips

  Three time points (upon obtaining informed consent, prior to injection and during injection)

• Numerical rating scale postoperatively

  Up to 72 hours following surgery

Study Arms (1)

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.

Procedure: VATS; Drug: Ropivacaine; Drug: Epinephrine

Interventions

VATS PROCEDURE

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

VATS block (ropivacaine + epinephrine)

Ropivacaine DRUG

30 mL 0.5% ropivacaine is used to achieve VATS block

VATS block (ropivacaine + epinephrine)

Epinephrine DRUG

1:400000 epinephrine is mixed with ropivacaine (local anesthetic) to reduce the risk of local anesthetic systemic toxicity

VATS block (ropivacaine + epinephrine)

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

MeSH Terms

Interventions

Thoracic Surgery, Video-Assisted; Ropivacaine; Epinephrine

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Jui-An Lin

CONTACT

+886-2-29307930; juian.lin@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 17, 2017
• Study Start: March 27, 2017
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: March 22, 2017

Record last verified: 2017-02