Effect of Superior Laryngeal Nerve Blocks on Patient Outcomes in Laryngeal Surgery
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension)
DrugPatients 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.
Superior laryngeal nerve block - Placebo (saline)
DrugPatients will receive a saline placebo of 2mL saline to the neck on the side of the vocal cord lesion during their surgery.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Superior laryngeal nerve blockExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1, 3 and 7 days after surgery2
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.
Time frame
Follow up appointment 2-4 weeks after surgery3
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.
Time frame
Postoperative appointment 2-4 weeks after surgerySecondary outcomes
1
Post-extubation cough
Clinical assessment of cough immediately following extubation from surgery using the following scale: * Grade 0: No cough. * Grade 1: Mild cough - the patient has occasional coughing that does not interfere with recovery or cause noticeable discomfort. No intervention is required. * Grade 2: Moderate cough - more than 1 episode of unsustained coughing lasting over 64 seconds causing discomfort and may temporarily delay recovery. Requires minimal supportive interventions (hydration, suctioning). * Grade 3: Severe cough - intense or continuous coughing lasting over 64 seconds that causes significant discomfort, delays recovery, or contributes to complications such as wound dehiscence or an airway obstruction. May require a medical intervention such as nebulization or repositioning. Grade 3 represents the worst outcome, characterized by significant discomfort, delayed recovery, or complications requiring medical intervention.
Time frame
5 minutes postoperativeSponsors and contacts
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Source ClinicalTrials.gov