Effect of Superior Laryngeal Nerve Blocks on Patient Outcomes in Laryngeal Surgery

Effect of Intraoperative Superior Laryngeal Nerve Blocks on Patient Outcomes in Microdirect Laryngoscopy for Benign Vocal Fold Lesions: A Randomized Trial

Patients undergoing surgery on their vocal cord will either receive a numbing injection to their throat or a saline injection during surgery. Symptoms such as how much coughing or pain patients have after surgery, as well as whether patient's voice gets better will be interrogated.

Study Overview

• Status: Recruiting
• Conditions: Vocal Cord Cyst; Vocal Cord Polyp; Vocal Cord Disease
• Intervention / Treatment: Drug: Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension); Drug: Superior laryngeal nerve block - Placebo (saline)

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Emma Thompson, MD; Phone Number: 973-972-2548; Email: ert46@njms.rutgers.edu

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Recruiting
      • Rutgers New Jersey Medical School
      • Contact: Sandra Oxley; Phone Number: 973-972-2548; Email: so514@njms.rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient is aged 18 years or older at time of consent
• Patient has suspected or confirmed benign vocal fold lesion
• Patient is planning to undergo direct laryngoscopy with excision of the vocal fold lesion
• Patient is English or Spanish speaking
• Patient is not pregnant per self report
• Patient is not incarcerated

Exclusion Criteria:

• Patient is not 18 years of age or older at consent date
• Patient does not speak English or Spanish
• Patient is currently pregnant or plans to become pregnant prior to their study procedure
• Patient has a laryngeal malignancy or found to find a laryngeal malignancy on final pathology
• Patient will not be undergoing direct laryngoscopy with excision of lesion
• Patient is unable to provide consent or complete study activities
• Patient is incarcerated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Superior laryngeal nerve block; Patients will receive a superior laryngeal nerve block consisting of 1 milliliter of 0.25% bupivacaine and milliliter of triamcinolone acetate 40 mg/ml to the neck on the side of the vocal cord lesion during their surgery.	Drug: Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension); Patients will receive a superior laryngeal nerve block consisting of 1 ml of 0.25% bupivacaine and 1mL of triamcinolone acetate 40 mg/ml to the neck on the side of the vocal cord lesion during their surgery.
Placebo Comparator: Placebo; Patients will receive a placebo of 2 milliliter saline injection to the neck on the side of the vocal cord lesion during their surgery.	Drug: Superior laryngeal nerve block - Placebo (saline); Patients will receive a saline placebo of 2mL saline to the neck on the side of the vocal cord lesion during their surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative cough	Cough severity index score. The Cough Severity Index (CSI) is a validated 10 question survey about cough severity with each question rated on a Likert Scale from 0-4, where 4 is most severe. The maximum score is 40 and the minimum score is 0, where 40 represents the most severe cough.	Follow up appointment 2-4 weeks after surgery
Postoperative voice outcome	Voice Handicap Index-10 (VHI-10) score. The VHI-10 is a validated 10 question survey about quality of life related to dysphonia with each question rated on a Likert Scale from 0-4, where 4 is most severe. The maximum score is 40 and the minimum score is 0, where 40 represents the most vocal handicap.	Postoperative appointment 2-4 weeks after surgery
Postoperative pain	We will record postoperative pain via the 100 mm visual analog scale (VAS). The minimum is 0, maximum is 100, and a higher score indicates more pain and thus a worse outcome.	1, 3 and 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-extubation cough	Clinical assessment of cough immediately following extubation from surgery using the following scale: Grade 0: No cough.; Grade 1: Mild cough - the patient has occasional coughing that does not interfere with recovery or cause noticeable discomfort. No intervention is required.; Grade 2: Moderate cough - more than 1 episode of unsustained coughing lasting over 64 seconds causing discomfort and may temporarily delay recovery. Requires minimal supportive interventions (hydration, suctioning).; Grade 3: Severe cough - intense or continuous coughing lasting over 64 seconds that causes significant discomfort, delays recovery, or contributes to complications such as wound dehiscence or an airway obstruction. May require a medical intervention such as nebulization or repositioning. Grade 3 represents the worst outcome, characterized by significant discomfort, delayed recovery, or complications requiring medical intervention.	5 minutes postoperative

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Kenneth Yan, MD, PhD, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Bupivacaine; Sodium Chloride
• Other Study ID Numbers: Pro2024002226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes