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Lidocaine Before Esophageal Manometry and Ambulatory pH Monitoring

Primary Purpose

Pain, Acute

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Saline spray
Lidocaine Hydrochloride
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring manometry, pH monitoring, lidocaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Centre hospitalier de l'Université de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine

Placebo (Saline)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Presence of pain during catheter insertion
As reported by patients on a standardized questionnaire

Secondary Outcome Measures

Global patient satisfaction
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
As reported by patients on a standardized questionnaire
Presence of complications during test recording
As reported by patients on a standardized questionnaire

Full Information

First Posted
May 9, 2019
Last Updated
January 17, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT03967197
Brief Title
Lidocaine Before Esophageal Manometry and Ambulatory pH Monitoring
Official Title
Is Lidocaine Useful Before Esophageal Manometry and Ambulatory pH Monitoring? A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 6, 2019 (Actual)
Primary Completion Date
August 5, 2020 (Actual)
Study Completion Date
August 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
manometry, pH monitoring, lidocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
Patients randomized to the lidocaine intervention will receive 2 sprays of lidocaine hydrochloride 10% in each nostril 3-5 minutes before their test.
Arm Title
Placebo (Saline)
Arm Type
Placebo Comparator
Arm Description
Patients randomized to placebo will receive 2 sprays of physiological saline in each nostril 3-5 minutes before their test.
Intervention Type
Drug
Intervention Name(s)
Saline spray
Intervention Description
Physiologic saline spray
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride
Intervention Description
Lidocaine hydrochloride 10% spray
Primary Outcome Measure Information:
Title
Presence of pain during catheter insertion
Description
As reported by patients on a standardized questionnaire
Time Frame
Assessed once immediately after exam on patient questionnaire
Secondary Outcome Measure Information:
Title
Global patient satisfaction
Description
As reported by patients on a standardized questionnaire (on scale of 1 to 5, 5 being highest satisfaction score)
Time Frame
Assessed once immediately after exam on patient questionnaire
Title
Presence of other complications during catheter insertion
Description
As reported by patients on a standardized questionnaire
Time Frame
Assessed once immediately after exam on patient questionnaire
Title
Presence of complications during test recording
Description
As reported by patients on a standardized questionnaire
Time Frame
Assessed once immediately after exam on patient questionnaire

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Centre hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Lidocaine Before Esophageal Manometry and Ambulatory pH Monitoring

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