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

NCT06734975 Phase 2 RECRUITING

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.

Details

Lead sponsor	Rutgers, The State University of New Jersey
Phase	Phase 2
Status	RECRUITING
Enrolment	28
Start date	2025-07-11
Completion	2026-12

Conditions

• Vocal Cord Disease
• Vocal Cord Polyp
• Vocal Cord Cyst

Interventions

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

Primary outcomes

• 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.

Countries

United States