Lidocaine Before Esophageal Manometry and Ambulatory pH Monitoring

Centre hospitalier de l'Université de Montréal (CHUM)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pain, Acute

Treatments: Drug: Saline spray; Drug: Lidocaine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03967197

2020-8355

Details and patient eligibility

About

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

Full 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.

Enrollment: 304 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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304 participants in 2 patient groups, including a placebo group

Lidocaine

Experimental group

Description:

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

Treatment:

Drug: Lidocaine Hydrochloride

Placebo (Saline)

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline spray