Lidocaine Before Esophageal Manometry and Ambulatory pH Monitoring

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967197
• Other study ID #: 2020-8355
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 6, 2019
• Est. completion date: August 5, 2020

Study information

• Verified date: January 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: August 5, 2020
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

Drug:
• Saline spray
Physiologic saline spray
• Lidocaine Hydrochloride
Lidocaine hydrochloride 10% spray

Locations

Country	Name	City	State
Canada	Centre hospitalier de l'Université de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of pain during catheter insertion	As reported by patients on a standardized questionnaire	Assessed once immediately after exam on patient questionnaire
Secondary	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
Secondary	Presence of other complications during catheter insertion	As reported by patients on a standardized questionnaire	Assessed once immediately after exam on patient questionnaire
Secondary	Presence of complications during test recording	As reported by patients on a standardized questionnaire	Assessed once immediately after exam on patient questionnaire