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NCT Number: NCT06734975

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

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.

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Key information

Conditions

Vocal Cord Disease Vocal Cord Cyst Vocal Cord Polyp

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

Location status: Recruiting

Location contact

Sandra Oxley

CONTACT

[email protected]

973-972-2548

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension)

Drug

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.

Superior laryngeal nerve block - Placebo (saline)

Drug

Patients will receive a saline placebo of 2mL saline to the neck on the side of the vocal cord lesion during their surgery.

Primary outcomes

  1. Postoperative pain

    Time frame: 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.

  2. Postoperative cough

    Time frame: 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.

  3. Postoperative voice outcome

    Time frame: 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 outcomes

  1. Post-extubation cough

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Thompson, MD

CONTACT

[email protected]

973-972-2548

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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