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

NCT05178485 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: STU-2020-0443
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Patients With a Diagnosis of Odynophonia

Outcome Measures

Primary Outcomes (1)

• Change in pain on the McGill Pain Questionnaire

  The McGill Pain Questionnaire (MPQ) is a valid and reliable measure of pain. The MPQ captures pain intensity on a 0 to 10 scale where 0 indicating no pain and 10 indicating severe pain

  Baseline, Visit 2 (approximately 1 week)

Study Arms (2)

The experimental group

EXPERIMENTAL

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.

Drug: Bupivacain

The control group

PLACEBO COMPARATOR

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.

Other: Normal Saline

Interventions

Bupivacain DRUG

FDA approved drug

Also known as: Kenalog-40

The experimental group

Normal Saline OTHER

FDA approved

The control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

MeSH Terms

Interventions

Bupivacaine; Triamcinolone; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 5, 2022
• Study Start: July 1, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share