Lidocaine Before Esophageal Manometry and Ambulatory pH Monitoring

Phase 2

Completed

• Conditions: Pain, Acute
• Interventions: Drug: Saline spray; Drug: Lidocaine Hydrochloride

• Registration Number: NCT03967197
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

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 Timeline

• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-30
• Study Start: 2019-08-06
• Primary Completion: 2020-08-05
• Study Completion: 2020-08-05
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (Saline)	Saline spray	Patients randomized to placebo will receive 2 sprays of physiological saline in each nostril 3-5 minutes before their test.
Lidocaine	Lidocaine Hydrochloride	Patients randomized to the lidocaine intervention will receive 2 sprays of lidocaine hydrochloride 10% in each nostril 3-5 minutes before their test.

Primary Outcome Measures

Name	Time	Method
Presence of pain during catheter insertion	Assessed once immediately after exam on patient questionnaire	As reported by patients on a standardized questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre hospitalier de l'Université de Montréal; 🇨🇦 Montréal, Quebec, Canada