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Completed

NCT Number: NCT03967197

Lidocaine Before Esophageal Manometry and Ambulatory pH Monitoring

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline spray

Drug

Physiologic saline spray

Lidocaine Hydrochloride

Drug

Lidocaine hydrochloride 10% spray

Primary outcomes

  1. Presence of pain during catheter insertion

    Time frame: Assessed once immediately after exam on patient questionnaire

    As reported by patients on a standardized questionnaire

Secondary outcomes

  1. Global patient satisfaction

    Time frame: 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)

  2. Presence of other complications during catheter insertion

    Time frame: Assessed once immediately after exam on patient questionnaire

    As reported by patients on a standardized questionnaire

  3. Presence of complications during test recording

    Time frame: Assessed once immediately after exam on patient questionnaire

    As reported by patients on a standardized questionnaire

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 30, 2019
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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