Study: Manometry With & Without Lidocaine

NCT03349112 | Completed DMC

• 3 other identifiers: 2015-0485A539772SMPH/SURGERY/SURGERY*SP
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Anesthetized

ACTIVE COMPARATOR

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; Behavioral: 2% Viscous Lidocaine

Non-Anesthetized

PLACEBO COMPARATOR

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

Interventions

4% Lidocaine Spray BEHAVIORAL

2% Viscous Lidocaine is applied to the nares as standard of care. In this intervention, 4% lidocaine spray is applied additionally.

Anesthetized

2% Viscous Lidocaine BEHAVIORAL

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

Anesthetized; Non-Anesthetized

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jodi Hernandez, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: November 21, 2017
• Study Start: December 22, 2015
• Primary Completion: November 9, 2018
• Study Completion: November 9, 2018
• Last Updated: October 2, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)