Study: Manometry With & Without Lidocaine

Normal Clinical Trial

Official title:

The Effect of Lidocaine on Perceived Comfort and Swallowing Pressures During High Resolution Pharyngeal Manometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349112
• Other study ID #: 2015-0485
• Secondary ID: A539772SMPH/SURG
• Status: Completed
• Phase: N/A
• Start date: December 22, 2015
• Est. completion date: November 9, 2018

Study information

• Verified date: October 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether subjects report a difference in comfort with High Resolution Pharyngeal Manometry (HRPM) conducted following application of lidocaine as an anesthetic as compared to HRPM conducted without anesthetic.

Description:

High resolution pharyngeal manometry (HRPM) is used for assessing swallowing pressure along the length of the pharynx and upper esophageal sphincter. Pressure measurements in the region of the velopharynx, tongue base, and upper esophageal sphincter are obtained by passing a catheter with pressure sensors through the patient's nose and past the upper esophageal sphincter. Patients are presented various volumes of liquid to swallow and potentially asked to perform postural strategies such as a head turn or chin tuck during swallowing while the catheter is in place. Clinically, approximately 90% of patients report various discomfort associated with the procedure. Discomfort can result in patient refusal to participate or an inaccurate picture of a patient's swallowing pressures. Conversely, use of anesthesia can potentially alter swallowing physiology.

Recent studies have studied the effects of lidocaine on penetration/aspiration and subject discomfort during flexible endoscopic evaluations, yet findings are inconclusive or contradictive. Investigators aim to determine whether subjects report a difference in comfort with HRPM conducted following application of lidocaine as an anesthetic as compared to HRPM conducted without anesthetic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 9, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Healthy male and female adults 18-65.

2. All races.

3. Able to consent for self.

Exclusion Criteria:

1. History of dysphagia.

2. History of previous pharyngeal or esophageal manometry.

3. History of facial fracture or abnormalities precluding passage of catheter through nares.

4. History of esophageal pathology including previous resection or perforation.

5. Pregnant

6. Known lidocaine allergy or sensitivity

Related Conditions & MeSH terms

• Normal

Intervention

Behavioral:
• 4% Lidocaine Spray
2% Viscous Lidocaine is applied to the nares as standard of care. In this intervention, 4% lidocaine spray is applied additionally.
• 2% Viscous Lidocaine
2% Viscous Lidocaine is applied to the nares as standard of care. This intervention is considered as the control group.

Locations

Country	Name	City	State
United States	University of Wisconsin - Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A quantifiable difference of perceived comfort reduction during HRPM with or without lidocaine as assessed through analysis of a visual analog scale.	Following HRPM without additional lidocaine and following HRPM with additional lidocaine, the subject will be asked to rate their level of comfort during the procedure using a visual analog scale.	Assessing the change of the visual analog scale between two procedural study visits. Data will be reported at study completion, an average of 1 year.