Effect of Intraoperative Superior Laryngeal Nerve Blocks on Patient Outcomes in Microdirect Laryngoscopy for Benign Vocal Fold Lesions: A Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Superior laryngeal nerve block
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.
干预措施: Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension) (Drug)
Placebo
Patients will receive a placebo of 2 milliliter saline injection to the neck on the side of the vocal cord lesion during their surgery.
干预措施: Superior laryngeal nerve block - Placebo (saline) (Drug)
结局指标
主要结局
Postoperative pain
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Post-extubation cough(5 minutes postoperative)
研究者
Kenneth Yan, MD, PhD
Assistant Professor, Laryngology
Rutgers, The State University of New Jersey