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

Phase 2

Not yet recruiting

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

• Registration Number: NCT06734975
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20
• Study Start: 2025-02
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Superior laryngeal nerve block	Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension)	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.
Placebo	Superior laryngeal nerve block - Placebo (saline)	Patients will receive a placebo of 2 milliliter saline injection to the neck on the side of the vocal cord lesion during their surgery.

Primary Outcome Measures

Name	Time	Method
Postoperative pain	1, 3 and 7 days after surgery	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.
Postoperative cough	Follow up appointment 2-4 weeks after surgery	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.
Postoperative voice outcome	Postoperative appointment 2-4 weeks after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Post-extubation cough	5 minutes postoperative	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.

Trial Locations

Locations (1)

Rutgers New Jersey Medical School; 🇺🇸 Newark, New Jersey, United States