NCT04426097

Brief Summary

Currently, there is a trend toward non-intubated anesthesia methods for video-assisted thoracic surgery in our hospital. During the surgery, intrathoracic vagus nerve blockade is suggested for inhibit cough reflex in previous paper. However, right and left side of vagus nerves both deep near the aorta or trachea respectively. To achieving the procedure may induce cough reflex by lobar traction even result vital organ damage. This study aims to apply alternative vagus nerve blockade at neck level via ultrasound guidance and test if the procedure real reduce cough reflex then previous method. We also follow up the patient's vital sign, vocal cord and diaphragm movement, horner syndrome and hoarseness to evaluating if cervical vagal blockade has the potential risk involve other surrounding nerves

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

June 11, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 31, 2020

Last Update Submit

June 9, 2020

Conditions

Video-assisted Thoracoscopic Surgery

Keywords

vagus nerve block

Outcome Measures

Primary Outcomes (1)

  • Effect of Cervical Vagal Blockade on Cough Incidence

    number of coughing episodes

    During the VATS procedure

Study Arms (2)

Cervical Vagal Blockade

EXPERIMENTAL
Procedure: Cervical Vagal Blockade

Without Blockade

PLACEBO COMPARATOR
Procedure: Without Blockade

Interventions

Cervical Vagal BlockadePROCEDURE

Cervical Vagal Blockade with 0.5 % ropivacaine 2.5 ml and 2% xylocaine 2.5 ml

Cervical Vagal Blockade
Without BlockadePROCEDURE

Without Blockade

Without Blockade

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults younger than 80 years old are scheduled for one-port video assisted thoracic surgery

You may not qualify if:

  • Anticipated difficult airway, Respiratory insufficiency,Vocal cord palsy,diaphragm palsy parkinsonism,previous stroke,tachycardia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Katlic MR, Facktor MA. Video-assisted thoracic surgery utilizing local anesthesia and sedation: 384 consecutive cases. Ann Thorac Surg. 2010 Jul;90(1):240-5. doi: 10.1016/j.athoracsur.2010.02.113.

    PMID: 20609784BACKGROUND

  • Chen KC, Cheng YJ, Hung MH, Tseng YD, Chen JS. Nonintubated thoracoscopic surgery using regional anesthesia and vagal block and targeted sedation. J Thorac Dis. 2014 Jan;6(1):31-6. doi: 10.3978/j.issn.2072-1439.2014.01.01.

    PMID: 24455173BACKGROUND

  • Chen JS, Cheng YJ, Hung MH, Tseng YD, Chen KC, Lee YC. Nonintubated thoracoscopic lobectomy for lung cancer. Ann Surg. 2011 Dec;254(6):1038-43. doi: 10.1097/SLA.0b013e31822ed19b.

    PMID: 21869676BACKGROUND

  • Lee YJ, Chung CC, Chou HC, Lin JA. Block for uniportal video-assisted thoracoscopic surgery: an ultrasound-guided, single-penetration, double-injection approach. Br J Anaesth. 2015 Nov;115(5):792-4. doi: 10.1093/bja/aev327. No abstract available.

    PMID: 26475808BACKGROUND

  • Dong Q, Liang L, Li Y, Liu J, Yin W, Chen H, Xu X, Shao W, He J. Anesthesia with nontracheal intubation in thoracic surgery. J Thorac Dis. 2012 Apr 1;4(2):126-30. doi: 10.3978/j.issn.2072-1439.2012.03.10.

    PMID: 22833817BACKGROUND

  • Giovagnorio F, Martinoli C. Sonography of the cervical vagus nerve: normal appearance and abnormal findings. AJR Am J Roentgenol. 2001 Mar;176(3):745-9. doi: 10.2214/ajr.176.3.1760745.

    PMID: 11222217BACKGROUND

  • Arsanious D, Khoury S, Martinez E, Nawras A, Filatoff G, Ajabnoor H, Darr U, Atallah J. Ultrasound-Guided Phrenic Nerve Block for Intractable Hiccups following Placement of Esophageal Stent for Esophageal Squamous Cell Carcinoma. Pain Physician. 2016 May;19(4):E653-6.

    PMID: 27228533BACKGROUND

  • Elias M. Cervical sympathetic and stellate ganglion blocks. Pain Physician. 2000 Jul;3(3):294-304.

    PMID: 16906187BACKGROUND

  • Polverino M, Polverino F, Fasolino M, Ando F, Alfieri A, De Blasio F. Anatomy and neuro-pathophysiology of the cough reflex arc. Multidiscip Respir Med. 2012 Jun 18;7(1):5. doi: 10.1186/2049-6958-7-5.

    PMID: 22958367BACKGROUND

Central Study Contacts

Lin Jui An, PhD

CONTACT

+886-66382736,greenscatter1031@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2020

First Posted

June 11, 2020

Study Start

July 1, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2022

Last Updated

June 11, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share