Vocal Cord Cyst, Vocal Cord Disease, Vocal Cord Polyp
Conditions
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.
Interventions
DRUGSuperior 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.
Patients will receive a saline placebo of 2mL saline to the neck on the side of the vocal cord lesion during their surgery.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactEmma Thompson, MD
Outcome results
None listed