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

NCT ID: NCT05309174

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-12-30

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.

Detailed Description

With the development of microsurgery, the vocal cord polypectomy by laryngoscopy has become a very mature surgery, under the laryngoscope. The surgery have some characteristics, that has a small trauma, shorter operative time, faster moving , but the strong stimulation of laryngeal surgery requires sufficient muscle relaxant condition, the greatest degree of reduce stress reaction, and waking up as soon as possible.

In the vocal cord polypectomy by laryngoscopy, the stimulation of throat often cause the nervous sympathetic excitement, including huge volatility in hemodynamics, fast heart rate, hypertension, cardiovascular serious adverse reactions such as ventricular arrhythmia, as placing the laryngoscope. Especially some patients are more obvious, who with a disease of hypertension, coronary atherosclerosis, tachycardia. It may cause myocardial ischemia and even other serious cardiovascular and cerebrovascular complications. In addition, it can also cause abnormal fluctuations in endocrine, immune and metabolism of the body, which has an important relationship with perioperative safety.

Superior laryngeal nerve block, blocking the laryngopharynx, epiglottis, tongue base, piriform recess and mucosa above the glottic fissure namely, can block the introduction of harmful stimuli and reduce pharyngeal stimulation during the perioperative period of endoscopic surgery. Bilateral superior laryngeal nerve block can reduce stress response effectively, maintaining hemodynamic stability, reducing perioperative adverse reactions and improving the safety of anesthesia. Furthermore, it can reduce the application of opioids and muscle relaxants during the operation, and shorten the time for patients to recover. Moreover, the vocal cords can be relaxed to provide good conditions for surgical operation. Accurate block of bilateral superior laryngeal nerve can also be used to provide good intraoperative and postoperative analgesia, under ultrasound guidance .

In this study, the anesthetic effect and patient status of general anesthesia and ultrasound guided superior laryngeal nerve block combined with general anesthesia were compared on the anesthesia of vocal cord polyp extraction under support laryngoscope.

The study method was to divide the subjects into experimental group and control group. The experimental group received ultrasound guided superior laryngeal nerve block combined with general anesthesia. However, the control group received all general anesthesia. The hemodynamic changes before endotracheal intubation (T1), during endotracheal intubation (T2), support laryngoscope placement (T3), immediately after extubation (T4), and 5minutes after extubation (T5) were recorded. The statistics of anesthetic dosage during operation were also recorded. Moreover, the investigators collect these results that the 9-item quality of recovery score (QOR-9) for 30 minutes and 60 minutes after extubation, the degree of cough immediately after extubation, 10 minutes, 1 hour and 4 hours after operation, and the degree of pharynx pain and hoarseness at 30 minutes, 2 hours, 4 hours and 24 hours after operation.

Conditions

Vocal Cord Polyp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

General anesthesia group

Patients received general anesthesia.

Group Type: NO_INTERVENTION

No interventions assigned to this group

General anesthesia combined laryngeal nerve block

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.

Group Type: EXPERIMENTAL

USG-guided iSLN block

Intervention Type: 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.

Interventions

USG-guided iSLN block

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• To undergo direct rigid endoscopic laryngosurgery
• ASAⅠ～Ⅱ

Exclusion Criteria

Coagulation disorders

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guizhou Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiangdi Yu, MD

Role: STUDY_CHAIR

Guizhou Provincial People's Hospital

Locations

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiangdi Yu, MD

Role: CONTACT

Xiangdi_Yu@163.com

008618212004663

Facility Contacts

Xiangdi Yu, MD

Role: primary

Xiangdi_Yu@163.com

008618212004663

Other Identifiers

789996

Identifier Type: -

Identifier Source: org_study_id