Treatment Efficacy of Local Anesthetic/Steroid Mixture Injection for Patients With Odynophonia
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Change in pain on the McGill Pain Questionnaire
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who report pain associated with voicing and are diagnosed with odynophonia
排除标准
- •• 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.)
研究组 & 干预措施
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.
干预措施: Bupivacain (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.
干预措施: Normal Saline (Other)
结局指标
主要结局
Change in pain on the McGill Pain Questionnaire
时间窗: Baseline, Visit 2 (approximately 1 week)
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
次要结局
未报告次要终点
研究者
Ted Mau
Professor
University of Texas Southwestern Medical Center