Nerve Blocks for Vocal Cord Surgery

ET
Overseen ByEmma Thompson, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Rutgers, The State University of New Jersey
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a numbing injection, known as a superior laryngeal nerve block, can reduce coughing and pain after vocal cord surgery. The study compares this treatment to a saline placebo. It targets individuals planning surgery to remove non-cancerous lesions on their vocal cords. Eligible participants must have a confirmed benign vocal cord lesion and plan to undergo surgery for it. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant medical advancements.

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.

Is there any evidence suggesting that the superior laryngeal nerve block is likely to be safe for humans?

Research has shown that superior laryngeal nerve blocks, which are numbing injections, are generally safe and well-tolerated. Studies have found that this procedure can effectively relieve pain during vocal cord surgeries.

In one study, patients who received this nerve block experienced positive short-term results and tolerated the procedure well. Another study found that using ultrasound to guide these nerve blocks reduces complications, enhancing safety.

Overall, evidence suggests that the superior laryngeal nerve block is safe, with few side effects reported. However, like any medical procedure, risks remain, so discussing these with a doctor is important.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for vocal cord issues, which often involve surgical techniques or systemic medications, the superior laryngeal nerve block offers a targeted approach. This method uses a combination of bupivacaine, a local anesthetic, and triamcinolone acetate, a steroid, delivered directly to the nerve near the vocal cord lesion. This targeted delivery can reduce pain and inflammation precisely where it's needed, potentially enhancing recovery and minimizing side effects compared to more generalized treatments. Researchers are excited about this approach because it promises quicker relief and recovery without affecting the entire body, making the procedure more efficient and patient-friendly.

What evidence suggests that the superior laryngeal nerve block is effective for vocal cord surgery?

In this trial, participants will receive either a Superior Laryngeal Nerve Block or a placebo during their vocal cord surgery. Research has shown that numbing the throat with a Superior Laryngeal Nerve Block can reduce symptoms like coughing and pain after vocal cord surgery. Studies have found that patients receiving this nerve block experience fewer issues, such as sore throats and coughs, compared to those who do not. This procedure involves numbing the throat to ease discomfort during and after surgery. Initial findings suggest it might also improve voice quality after surgery. Overall, this nerve block appears to be a promising option for reducing post-surgery problems in vocal cord patients.13567

Who Is on the Research Team?

KY

Kenneth Yan, MD, PhD

Principal Investigator

Rutgers, The State University of New Jersey

Are You a Good Fit for This Trial?

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.
See 3 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Superior laryngeal nerve blockExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

Citations

The Efficacy of Ultrasound-Guided Superior Laryngeal ...In the current study, we assessed the effect of the ultrasound-guided internal branch of the upper laryngeal nerve (USG-guided iSLN) block ...
Effect of Superior Laryngeal Nerve Blocks on Patient ...Patients will receive a placebo of 2 milliliter saline injection to the neck on the side of the vocal cord lesion during their surgery. Intervention/Treatment ...
A comparative study on ultrasound guided superior ...In this study, there is a significantly lower incidence of complications like sore throat and cough in Group B patients than that of Group A patients (P value < ...
Nerve Blocks for Vocal Cord SurgeryResearch 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 ...
Indications and Short-Term Outcomes for In-Office ...SLN block can be an effective component of treatment for a variety of ILS symptoms. Patients may experience some improvement after 1 injection.
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37164832/
Superior Laryngeal Nerve Block in Transcutaneous Vocal ...SLNB might be safe and effective for anesthesia in transcutaneous VFI. SLNB could be a good anesthetic option for patients with poor ...
Superior Laryngeal Nerve Block in Transcutaneous Vocal ...Herein, we present a pilot study to evaluate the feasibility and safety of SLNB for transcutaneous VFI and explored its usefulness. Methods. Fifty-nine patients ...
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