Study: Manometry With & Without Lidocaine

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Completed

CT.gov ID

NCT03349112

Collaborator

(none)

Enrollment

Location

Arms

34.6

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Normal	Behavioral: 4% Lidocaine Spray Behavioral: 2% Viscous Lidocaine	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

During both the anesthetized and non-anesthetized conditions as per standard of care, the study team member will apply 1 mL of 2% viscous lidocaine to each nares prior to the passage of the catheter. During only the anesthetized condition, subjects will receive up to .8 ml of a 4% Lidocaine spray to both nares.During both the anesthetized and non-anesthetized conditions as per standard of care, the study team member will apply 1 mL of 2% viscous lidocaine to each nares prior to the passage of the catheter. During only the anesthetized condition, subjects will receive up to .8 ml of a 4% Lidocaine spray to both nares.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Dec 22, 2015

Actual Primary Completion Date :

Nov 9, 2018

Actual Study Completion Date :

Nov 9, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Anesthetized 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.	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. Behavioral: 2% Viscous Lidocaine 2% Viscous Lidocaine is applied to the nares as standard of care. This intervention is considered as the control group.
Placebo Comparator: Non-Anesthetized 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 .	Behavioral: 2% Viscous Lidocaine 2% Viscous Lidocaine is applied to the nares as standard of care. This intervention is considered as the control group.

Arm

Intervention/Treatment

Active Comparator: Anesthetized

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.

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.

Behavioral: 2% Viscous Lidocaine

2% Viscous Lidocaine is applied to the nares as standard of care. This intervention is considered as the control group.

Placebo Comparator: Non-Anesthetized

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 .

Behavioral: 2% Viscous Lidocaine

2% Viscous Lidocaine is applied to the nares as standard of care. This intervention is considered as the control group.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male and female adults 18-65.
All races.
Able to consent for self.

Exclusion Criteria:

History of dysphagia.
History of previous pharyngeal or esophageal manometry.
History of facial fracture or abnormalities precluding passage of catheter through nares.
History of esophageal pathology including previous resection or perforation.
Pregnant
Known lidocaine allergy or sensitivity