Lidocaine Before Esophageal Manometry and Ambulatory pH Monitoring

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Acute

Intervention / Treatment
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* Drug: Saline spray
* Drug: Lidocaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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manometry, pH monitoring, lidocaine