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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Superior laryngeal nerve block | Experimental | 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 | Placebo Comparator | Patients will receive a placebo of 2 milliliter saline injection to the neck on the side of the vocal cord lesion during their surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-extubation cough | Clinical assessment of cough immediately following extubation from surgery using the following scale:
Grade 3 represents the worst outcome, characterized by significant discomfort, delayed recovery, or complications requiring medical intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma Thompson, MD | Contact | 973-972-2548 | ert46@njms.rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kenneth Yan, MD, PhD | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers New Jersey Medical School | Recruiting | Newark | New Jersey | 07103 | United States |
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|
| 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. |
|
| 5 minutes postoperative |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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