Treatment Efficacy of Local Anesthetic/Steroid Mixture Injection for Patients With Odynophonia

NCT ID: NCT05178485

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2027-12-31

Brief Summary

This is a double-blind, randomized, placebo-controlled trial. A total of 40 subjects will be randomized to experimental group (receiving bupivacaine/triamcinolone mixture) or control group (receiving saline injection). Two injections will be given one week apart. The primary outcome measure is the reduction in pain on the abbreviated McGill Pain Questionnaire (MPQ).

Detailed Description

This is a double-blind, randomized, placebo-controlled trial. A total of 40 subjects will be randomized to experimental group (receiving bupivacaine/triamcinolone mixture) or control group (receiving saline injection). Two injections will be given one week apart. The primary outcome measure is the reduction in pain on the abbreviated McGill Pain Questionnaire (MPQ).

The injection of a mixture of local anesthetic/steroid into the thyrohyoid membrane to target the internal branch of superior laryngeal nerve (SLN) has been shown to be effective for some patients with chronic cough. Although anecdotal experience suggests this injection may also be effective in alleviating neck pain in patients with odynophonia (pain associated with voicing), there are no prospective studies to define the efficacy of this injection for odynophonia. The purpose of the study is to conduct a randomized, placebo-controlled study on the effect of local anesthetic/steroid injection for patients with odynophonia.

Recruitment/Consent Patients with a diagnosis of odynophonia seen at the UT Southwestern Voice Center will be informed of the study and given the opportunity to participate. Consent will be carried out by the study team members.

Randomization Subjects will be assigned a Study ID sequentially by the study coordinator upon enrollment. Each study ID (from Subject 01 to Subject 40) will be a priori assigned to either the experimental group or the control group using a randomization function in Excel.

Blinding Subjects will be blinded to group assignment. The physicians who are the treating providers of the subjects and who will perform the injections will also be blinded to group assignment. At each clinic visit for a subject's injection, the study coordinator will inform the clinic nurse of the group assignment, and the nurse will draw up the corresponding 2 mL injectate (either the bupivacaine/triamcinolone mixture or saline) and wrap the syringe in foil. The syringe will then be provided to the physician for the injection.

Injections Injections will be performed in the usual fashion as for standard of care injections commonly performed. The subject will be seated in the exam chair with the chair slightly inclined to extend the neck.

Only unilateral injections will be performed even for patients with bilateral pain, so that the dose is the same for all subjects. Patients with bilateral pain will be asked to choose one side for the injection for the duration of the study. The patients will only be billed for a regular clinic visit and not for the actual injections.

Subjects in the Experimental Group will received a 2 mL injection consisting of 1 mL of 0.5% bupivacaine (5 mg bupivacaine-HCL) and 1 mL Kenalog-40 (40 mg triamcinolone acetonide). Subjects in the Control Group will receive 2 mL saline. A 1.5-in, 25G or 27G needle will be used.

Outcome Instruments The treatment progress/outcome will be based on questionnaires (modified version of McGill-Melzack Pain Questionnaire, Numeric Pain Scale, Brief Pain Inventory, Vocal Tract Discomfort scale and Voice Handicap Index-10) and the clinician's auditory-perceptual and acoustic analysis of voice. The data will be taken during the initial evaluation, at each treatment session, and post-treatment.

Conditions

Patients With a Diagnosis of Odynophonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

The experimental group

At each clinic visit for a subject's injection, the study coordinator will inform the clinic nurse of the group assignment, and the nurse will draw up the corresponding 2 mL injectate (either the bupivacaine/triamcinolone mixture) and wrap the syringe in foil. The syringe will then be provided to the physician for the injection.

Group Type: EXPERIMENTAL

Bupivacain

Intervention Type: DRUG

FDA approved drug

The control group

At each clinic visit for a subject's injection, the study coordinator will inform the clinic nurse of the group assignment, and the nurse will draw up the corresponding 2 mL saline and wrap the syringe in foil. The syringe will then be provided to the physician for the injection.

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: OTHER

FDA approved

Interventions

Bupivacain

FDA approved drug

Intervention Type: DRUG

Normal Saline

FDA approved

Intervention Type: OTHER

Other Intervention Names

Kenalog-40

Eligibility Criteria

Inclusion Criteria

• Patients who report pain associated with voicing and are diagnosed with odynophonia

Exclusion Criteria

• • Vocal fold mobility or tissue abnormality

• history of jaw surgery/TMJ
• history of neck surgery or trauma
• Uncontrolled reflux. (patient's scoring on Reflux Symptom Index(RSI) is 13 or higher: Normative data suggests that a RSI of greater than or equal to 13 is clinically significant.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ted Mau

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

STU-2020-0443

Identifier Type: -

Identifier Source: org_study_id