Lidocaine Before Esophageal Manometry and Ambulatory pH Monitoring

Is Lidocaine Useful Before Esophageal Manometry and Ambulatory pH Monitoring? A Randomized Controlled Study

A randomized controlled trial comparing esophageal manometry and ambulatory pH monitoring test tolerance in the presence versus in the absence of topical lidocaine.

Study Overview

• Status: Completed
• Conditions: Pain, Acute
• Intervention / Treatment: Drug: Lidocaine Hydrochloride; Drug: Saline spray

Detailed Description

Conventionally, topical nasopharyngeal anesthesia is applied to improve the tolerance of esophageal manometry and ambulatory pH monitoring. However, there is currently no data to support this practice. This randomized controlled trial of lidocaine versus placebo applied before these tests will evaluate the benefit of topical lidocaine anesthesia.

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada
      • Centre Hospitalier de l'Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Adult patients undergoing esophageal manometry or ambulatory pH monitoring at our center who are able to read and consent to participate in the study.

Exclusion Criteria:

• Patients < 18 years
• Incapacity to provide consent
• History of lidocaine allergy
• Current pregnancy
• Previous esophageal manometry or ambulatory pH monitoring in the last 14 days
• Previous participation in the study
• Severe cirrhosis (Child-Pugh C)
• Severe chronic kidney disease (eGFR<30 mL/min/1.73m2)
• Severe heart failure (New York Heart Association Functional Classification 3-4)
• Severe respiratory failure (dyspnea or oxygen-dependent at rest)
• Any active severe incapacitating chronic or acute medical disease
• Active hospitalization
• Ulcerated, atrophic, infected or recently burned (in the last 30 days) nasopharynx
• Recent surgery involving the nasopharynx (in the last 30 days)
• Severe chronic pain (ex. regular daily use of opioids)
• Previous stroke or any neurological lesion with resulting current sensory deficit
• Major neurocognitive disorder
• Any active severe incapacitating chronic or acute psychiatric disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine; Patients randomized to the lidocaine intervention will receive 2 sprays of lidocaine hydrochloride 10% in each nostril 3-5 minutes before their test.	Drug: Lidocaine Hydrochloride; Lidocaine hydrochloride 10% spray
Placebo Comparator: Placebo (Saline); Patients randomized to placebo will receive 2 sprays of physiological saline in each nostril 3-5 minutes before their test.	Drug: Saline spray; Physiologic saline spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of pain during catheter insertion	As reported by patients on a standardized questionnaire	Assessed once immediately after exam on patient questionnaire

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global patient satisfaction	As reported by patients on a standardized questionnaire (on scale of 1 to 5, 5 being highest satisfaction score)	Assessed once immediately after exam on patient questionnaire
Presence of other complications during catheter insertion	As reported by patients on a standardized questionnaire	Assessed once immediately after exam on patient questionnaire
Presence of complications during test recording	As reported by patients on a standardized questionnaire	Assessed once immediately after exam on patient questionnaire

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2019
• Primary Completion (Actual): August 5, 2020
• Study Completion (Actual): August 5, 2020

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Estimate): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: lidocaine; manometry; pH monitoring
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2020-8355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No