Nerve Blocks for Vocal Cord Surgery

Overseen By Emma Thompson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Laryngeal malignancy, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

28 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Superior Laryngeal Nerve Block for vocal cord surgery?

Research shows that Superior Laryngeal Nerve Block can help with symptoms like cough and pain related to the larynx (voice box), and it has been used successfully to improve recovery and reduce discomfort during vocal cord surgeries. ^{1 2 3 4 5}

Is the superior laryngeal nerve block safe for humans?

Research shows that using ultrasound to guide superior laryngeal nerve blocks can be successful with fewer complications, and studies have evaluated its safety for conditions like neurogenic cough and vocal fold injections. ^{1 6 7 8 9}

How is the superior laryngeal nerve block treatment different from other treatments for vocal cord surgery?

The superior laryngeal nerve block is unique because it involves injecting a combination of steroids and anesthetic directly at the nerve site, which can help manage symptoms like cough and pain associated with vocal cord surgery. This approach is different from standard treatments as it targets the nerve directly, potentially reducing the need for systemic medications and improving recovery. ^{1 3 4 5 10}

What is the purpose of this trial?

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.

Research Team

Kenneth Yan, MD, PhD

Principal Investigator

Rutgers, The State University of New Jersey

Eligibility Criteria

This trial is for adults over 18 with benign vocal cord lesions who are undergoing direct laryngoscopy surgery. Participants must speak English or Spanish. It's not open to those with head, neck, ear, nose, throat cancers in the last 5 years, pregnant women, prisoners, or anyone not having the specified surgery.

Inclusion Criteria

I am scheduled for a throat surgery to remove or sample a lesion.

I have non-cancerous growths on my vocal cords.

Exclusion Criteria

Patients who are pregnant

I am under 18 years old.

I am not scheduled for a throat biopsy or surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Patients undergo microdirect laryngoscopy with either a superior laryngeal nerve block or a placebo saline injection

1 day

1 visit (in-person)

Immediate Postoperative

Assessment of post-extubation cough immediately following surgery

5 minutes

Postoperative Monitoring

Monitoring of postoperative pain and cough severity at 1, 3, and 7 days after surgery

1 week

Follow-up

Assessment of postoperative voice outcome and cough severity index at follow-up appointment

2-4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Superior Laryngeal Nerve Block

Trial Overview The study tests if a numbing injection (Bupivacaine and triamcinolone acetonide) versus a saline placebo can reduce coughing or pain and improve voice outcomes after vocal cord surgery.

Participant Groups

Group I: Superior laryngeal nerve block Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

Patients will receive a placebo of 2 milliliter saline injection to the neck on the side of the vocal cord lesion during their surgery.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

References

1. United States pubmed.ncbi.nlm.nih.gov

Indications and Short-Term Outcomes for In-Office Therapeutic Superior Laryngeal Nerve Block. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The Application of Superior Laryngeal Nerve Block for Non-Cough Laryngeal Hypersensitivity. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The Role of Bilateral Superior Laryngeal Nerve Block in Managing Refractory Chronic Cough. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Longitudinal Follow-up of Superior Laryngeal Nerve Block for Chronic Neurogenic Cough. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The Efficacy of Ultrasound-Guided Superior Laryngeal Nerve Block as an Adjuvant to General Anesthesia during Suspension Laryngoscopy Vocal Cord Polypectomy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Ultrasound guided superior laryngeal nerve block as an adjuvant to generalanesthesia during endoscopic laryngeal surgery: A prospective, randomized, double-blind trial. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Superior Laryngeal Nerve Block in Transcutaneous Vocal Fold Injection: A Pilot Study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Prospective randomized study on injury of the external branch of the superior laryngeal nerve during thyroidectomy comparing intraoperative nerve monitoring and a conventional technique. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The Efficacy of Superior Laryngeal Nerve Block for Neurogenic Cough: A Placebo-Controlled Trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Superior laryngeal nerve block for neurogenic cough: A case series. [2022]