Lidocaine Before Esophageal Manometry and Ambulatory pH Monitoring

NCT ID: NCT03967197

Last Updated: 2023-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-06
• Study Completion Date: 2020-08-05

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.

Conditions

Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine

Patients randomized to the lidocaine intervention will receive 2 sprays of lidocaine hydrochloride 10% in each nostril 3-5 minutes before their test.

Group Type: EXPERIMENTAL

Lidocaine Hydrochloride

Intervention Type: DRUG

Lidocaine hydrochloride 10% spray

Placebo (Saline)

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

Group Type: PLACEBO_COMPARATOR

Saline spray

Intervention Type: DRUG

Physiologic saline spray

Interventions

Saline spray

Physiologic saline spray

Intervention Type: DRUG

Lidocaine Hydrochloride

Lidocaine hydrochloride 10% spray

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2020-8355

Identifier Type: -

Identifier Source: org_study_id