Lidocaine Before Esophageal Manometry and Ambulatory pH Monitoring

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03967197

Enrollment

304

Registered

2019-05-30

Start date

2019-08-06

Completion date

2020-08-05

Last updated

2023-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Acute

Keywords

manometry, pH monitoring, lidocaine

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.

Interventions

DRUGSaline spray

Physiologic saline spray

DRUGLidocaine Hydrochloride

Lidocaine hydrochloride 10% spray

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026