Lidocaine Before Esophageal Manometry and Ambulatory pH Monitoring

NCT03967197 | Completed Phase 2

• 1 other identifier: 2020-8355
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Acute

Keywords

manometry; pH monitoring; lidocaine

Outcome Measures

Primary Outcomes (1)

• Presence of pain during catheter insertion

  As reported by patients on a standardized questionnaire

  Assessed once immediately after exam on patient questionnaire

Secondary Outcomes (3)

• Global patient satisfaction

  Assessed once immediately after exam on patient questionnaire

• Presence of other complications during catheter insertion

  Assessed once immediately after exam on patient questionnaire

• Presence of complications during test recording

  Assessed once immediately after exam on patient questionnaire

Study Arms (2)

Lidocaine

EXPERIMENTAL

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

Placebo (Saline)

PLACEBO COMPARATOR

Patients randomized to placebo will receive 2 sprays of physiological saline in each nostril 3-5 minutes before their test.

Drug: Saline spray

Interventions

Saline spray DRUG

Physiologic saline spray

Placebo (Saline)

Lidocaine Hydrochloride DRUG

Lidocaine hydrochloride 10% spray

Lidocaine

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 30, 2019
• Study Start: August 6, 2019
• Primary Completion: August 5, 2020
• Study Completion: August 5, 2020
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)