The Study of Bilateral Upper Laryngeal Nerve Block for Supporting the Removal of Vocal Cord Polyps Under Laryngoscopy

NCT05309174 | Unknown

• 1 other identifier: 789996
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

With the continuous development of microsurgery, supporting laryngoscopy acoustic polyp removal has become a very mature clinical operation. The operation has small trauma, short operation time, fast turnover and needing to wake up as soon as possible, but the supporting laryngoscopy has great stimulation to the throat and great hemodynamic fluctuations. This study aims to evaluate the efficacy of ultrasound guided superior laryngeal nerve block as an adjuvant to general anesthesia during vocal cord polypectomy by laryngoscopy.

Conditions

Vocal Cord Polyp

Keywords

Ultrasound Guided Superior Laryngeal Nerve Block; Vocal Cord Polypectomy by Laryngoscopy

Outcome Measures

Primary Outcomes (12)

• The degree of severity of sore-throat at just before extubation (bucking on the ETT)

  Postoperative Sore-throat was assessed at just before extubation (bucking on the ETT) using a 4 grade scales. The degree of severity of sore throat is divided into four grades, grade 0: No sore throat, grade 1: Mild sore throat (complains of sore throat only upon inquiry) , grade 2: Moderate sore throat (complains of sore throat on his/her own), grade 3 :Severe sore throat (severe pain associated with marked change in voice).

  At just before extubation (bucking on the ETT).

• The degree of severity of sore-throat at the time point of 10 minutes after extubation

  Postoperative Sore-throat was assessed at 10 minutes after extubation using a 4 grade scales. The degree of severity of sore throat is divided into four grades, grade 0: No sore throat, grade 1: Mild sore throat (complains of sore throat only upon inquiry) , grade 2: Moderate sore throat (complains of sore throat on his/her own), grade 3 :Severe sore throat (severe pain associated with marked change in voice) .

  At the time point of 10 minutes after extubation.

• The degree of severity of sore-throat at the time point of 1 hour after extubation

  Postoperative Sore-throat was assessed at 1 hour after extubation using a 4 grade scales. The degree of severity of sore throat is divided into four grades, grade 0: No sore throat, grade 1: Mild sore throat (complains of sore throat only upon inquiry) , grade 2: Moderate sore throat (complains of sore throat on his/her own), grade 3 :Severe sore throat (severe pain associated with marked change in voice) .

  At the time point of 1 hour after extubation.

• The degree of severity of sore-throat at the time point of 4 hour after extubation

  Postoperative Sore-throat was assessed at 1 hour after extubation using a 4 grade scales. The degree of severity of sore throat is divided into four grades, grade 0: No sore throat, grade 1: Mild sore throat (complains of sore throat only upon inquiry) , grade 2: Moderate sore throat (complains of sore throat on his/her own), grade 3 :Severe sore throat (severe pain associated with marked change in voice) .

  At the time point of 4 hour after extubation.

• The degree of severity of cough at the time point of 30 minutes following extubation

  The degree of severity of cough is divided into four grades, grade 0: No cough, grade 1: Light or single cough, grade 2: Obvious to the observer, grade 3:Aphonia.

  At the time point of 30 minutes following extubation.

• The degree of severity of cough at the time point of 2 hours following extubation

  The degree of severity of cough is divided into four grades, grade 0: No cough, grade 1: Light or single cough, grade 2: Obvious to the observer, grade 3:Aphonia.

  At the time point of 2 hours following extubation.

• The degree of severity of cough at the time point of 4 hours following extubation

  The degree of severity of cough is divided into four grades, grade 0: No cough, grade 1: Light or single cough, grade 2: Obvious to the observer, grade 3:Aphonia.

  At at the time point of 4 hours following extubation.

• The degree of severity of cough at the time point of 24 hours following extubation

  The degree of severity of cough is divided into four grades, grade 0: No cough, grade 1: Light or single cough, grade 2: Obvious to the observer, grade 3:Aphonia.

  At the time point of 24 hours following extubation.

• The degree of severity of hoarseness at the time point of 30 minutes following extubation.

  The degree of hoarseness is divided into four grades, grade 0: None, grade 1:Noted by the patient, grade 2:More than one episode of unsustained (65 seconds) coughing, grade 3: Sustained (65 seconds) and Repetitive cough with head lift.

  At the time point of 30 minutes following extubation.

• The degree of severity of hoarseness at the time point of 2 hours following extubation.

  The degree of hoarseness is divided into four grades, grade 0: None, grade 1:Noted by the patient, grade 2:More than one episode of unsustained (65 seconds) coughing, grade 3: Sustained (65 seconds) and Repetitive cough with head lift.

  At the time point of 2 hours following extubation.

• The degree of severity of hoarseness at the time point of 4 hours following extubation.

  The degree of hoarseness is divided into four grades, grade 0: None, grade 1:Noted by the patient, grade 2:More than one episode of unsustained (65 seconds) coughing, grade 3: Sustained (65 seconds) and Repetitive cough with head lift.

  At the time points of 4 hours following extubation.

• The degree of severity of hoarseness at the time point of 24 hours following extubation.

  The degree of hoarseness is divided into four grades, grade 0: None, grade 1:Noted by the patient, grade 2:More than one episode of unsustained (65 seconds) coughing, grade 3: Sustained (65 seconds) and Repetitive cough with head lift.

  At the time point of 24 hours following extubation.

Secondary Outcomes (4)

• Mean arterial pressure ( MAP)

  Before endotracheal intubation (T1), during endotracheal intubation (T2), support laryngoscope placement (T3), immediately after extubation (T4), and 5 minutes after extubation (T5)

• Heart rate (HR)

  Before endotracheal intubation (T1), during endotracheal intubation (T2), support laryngoscope placement (T3), immediately after extubation (T4), and 5 minutes after extubation (T5)

• The 9-item quality of recovery score (QOR-9)

  After extubation for 30 minutes and 60 minutes.

• Anesthetic dosage

  During operation

Study Arms (2)

General anesthesia group

NO INTERVENTION

Patients received general anesthesia.

General anesthesia combined laryngeal nerve block

EXPERIMENTAL

Group L received ultrasound-guided internal branch of the upper laryngeal nerve block (USG-guided iSLN block) bilaterally with 5 ml of 0.375% ropivacaine, along with general anesthesia.

Procedure: USG-guided iSLN block

Interventions

USG-guided iSLN block PROCEDURE

Ultrasound-guided internal branch of the upper laryngeal nerve block (USG-guided iSLN block) bilaterally with 5 ml of 0.375% ropivacaine , before general anesthesia.

General anesthesia combined laryngeal nerve block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To undergo direct rigid endoscopic laryngosurgery
• ASAⅠ～Ⅱ

You may not qualify if:

• Coagulation disorders
• A history of neck surgery or an implant in the neck area
• Mental illness

Sponsors & Collaborators

• Guizhou Provincial People's Hospital: lead

Study Sites (1)

Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550003, China

RECRUITING

Study Officials

• Xiangdi Yu, MD

  Guizhou Provincial People's Hospital

  STUDY CHAIR

Central Study Contacts

Xiangdi Yu, MD

CONTACT

008618212004663; Xiangdi_Yu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: April 4, 2022
• Study Start: November 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: December 30, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

CN (1)