Study: Manometry With & Without Lidocaine

• ClinicalTrials.gov Identifier: NCT03349112
• Recruitment Status: Completed
• First Posted: November 21, 2017
• Last Update Posted: October 2, 2019
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

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	Not Applicable

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 (Clinical Trial)
• 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.
• 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: December 22, 2015
• Actual Primary Completion Date: November 9, 2018
• Actual Study Completion Date: November 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.

Outcome Measures

Primary Outcome Measures :

1. A quantifiable difference of perceived comfort reduction during HRPM with or without lidocaine as assessed through analysis of a visual analog scale. [ Time Frame: 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

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Wisconsin

University of Wisconsin - Madison

Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

• Principal Investigator: Jodi Hernandez, MS; University of Wisconsin, Madison

More Information

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT03349112
• Other Study ID Numbers: 2015-0485; A539772 ( Other Identifier: UW Madison ); SMPH/SURGERY/SURGERY*SP ( Other Identifier: UW Madison )
• First Posted: November 21, 2017
• Last Update Posted: October 2, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Wisconsin, Madison:

Manometry; Lidocaine; Pharyngeal; High Resolution Pharyngeal Manometry (HRPM); Pressure

Additional relevant MeSH terms:

Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action