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

Phase 2RecruitingNCT06734975

Rutgers, The State University of New Jersey28 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Vocal Cord Disease Vocal Cord Polyp Vocal Cord Cyst

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rutgers New Jersey Medical School

Newark, New Jersey, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 1, 3 and 7 days after surgery

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.

Time frame: 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.

Time frame: Postoperative appointment 2-4 weeks after surgery

Secondary Outcomes

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.

Central Contacts

Emma Thompson, MD

CONTACT

973-972-2548 ert46@njms.rutgers.edu

Data from ClinicalTrials.gov

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