Study: Manometry With & Without Lidocaine

Not Applicable

Completed

• Conditions: Normal
• Interventions: Behavioral: 4% Lidocaine Spray; Behavioral: 2% Viscous Lidocaine

• Registration Number: NCT03349112
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-12-22
• Study First Submitted: 2017-08-31
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-21
• Primary Completion: 2018-11-09
• Study Completion: 2018-11-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Anesthetized	2% Viscous Lidocaine	A study team member will apply 1 mL of 2% viscous lidocaine to each nares prior to the passage of the catheter, Participants in this group will additionally receive .8 mL of a 4% Lidocaine spray to both nares prior to HRPM.
Anesthetized	4% Lidocaine Spray	A study team member will apply 1 mL of 2% viscous lidocaine to each nares prior to the passage of the catheter, Participants in this group will additionally receive .8 mL of a 4% Lidocaine spray to both nares prior to HRPM.
Non-Anesthetized	2% Viscous Lidocaine	A study team member will apply 1 mL of 2% viscous lidocaine to each nares prior to the passage of the catheter. Randomized participants in this group will not receive .8 mL of a 4% Lidocaine spray prior to HRPM .

Primary Outcome Measures

Name	Time	Method
A quantifiable difference of perceived comfort reduction during HRPM with or without lidocaine as assessed through analysis of 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.	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.

Trial Locations

Locations (1)

University of Wisconsin - Madison; 🇺🇸 Madison, Wisconsin, United States