Pain, AcutePhase 2/3NCT03967197
Lidocaine Before Esophageal Manometry and Ambulatory pH Monitoring
A Phase 2/3 study testing Saline spray and Lidocaine Hydrochloride in people with Pain, Acute, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
A randomized controlled trial comparing esophageal manometry and ambulatory pH monitoring test tolerance in the presence versus in the absence of topical lidocaine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Saline spray and Lidocaine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 1 siteCanada
- Study dates
- 6 Aug 2019to 5 Aug 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients undergoing esophageal manometry or ambulatory pH monitoring at our center who are able to read and consent to participate in the study.
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Is Lidocaine Useful Before Esophageal Manometry and Ambulatory pH Monitoring? A Randomized Controlled Study
A randomized controlled trial comparing esophageal manometry and ambulatory pH monitoring test tolerance in the presence versus in the absence of topical lidocaine.
Read the 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
- Being tested
- Saline spray, Lidocaine Hydrochloride
- Keywords
- manometry, pH monitoring, lidocaine
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline sprayDrug
Physiologic saline spray
Lidocaine HydrochlorideDrug
Lidocaine hydrochloride 10% spray
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Patients randomized to the lidocaine intervention will receive 2 sprays of lidocaine hydrochloride 10% in each nostril 3-5 minutes before their test. Receives: Drug: Lidocaine Hydrochloride |
| Placebo (Saline) | Placebo comparator | Patients randomized to placebo will receive 2 sprays of physiological saline in each nostril 3-5 minutes before their test. Receives: Drug: Saline spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of pain during catheter insertion
As reported by patients on a standardized questionnaire
Measured: Assessed once immediately after exam on patient questionnaire
Secondary outcomes (3)
Global patient satisfaction
As reported by patients on a standardized questionnaire (on scale of 1 to 5, 5 being highest satisfaction score)
Measured: Assessed once immediately after exam on patient questionnaire
Presence of other complications during catheter insertion
As reported by patients on a standardized questionnaire
Measured: Assessed once immediately after exam on patient questionnaire
Presence of complications during test recording
As reported by patients on a standardized questionnaire
Measured: Assessed once immediately after exam on patient questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start6 Aug 2019
- Primary completion5 Aug 2020
- Study completion5 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967197
- Sponsor's protocol ID
- 2020-8355
- Status last verified
- Jan 2023
- First submitted
- 9 May 2019
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Lidocaine Useful Before Esophageal Manometry and Ambulatory pH Monitoring? A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03967197
- Acronym / sponsor ID
- 2020-8355
- Conditions
- Pain, Acute
- Keywords
- manometry, pH monitoring, lidocaine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 5 Aug 2020 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: Lidocaine HydrochloridePatients randomized to the lidocaine intervention will receive 2 sprays of lidocaine hydrochloride 10% in each nostril 3-5 minutes before their test. |
| Placebo (Saline) | Placebo comparator | Drug: Saline sprayPatients randomized to placebo will receive 2 sprays of physiological saline in each nostril 3-5 minutes before their test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing esophageal manometry or ambulatory pH monitoring at our center who are able to read and consent to participate in the study.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline sprayPhysiologic saline spray | Drug | Placebo (Saline) |
| Lidocaine HydrochlorideLidocaine hydrochloride 10% spray | Drug | Lidocaine |
Primary outcome
Presence of pain during catheter insertion
Time frame: Assessed once immediately after exam on patient questionnaire
As reported by patients on a standardized questionnaire
3 secondary outcomes
Global patient satisfaction
Time frame: Assessed once immediately after exam on patient questionnaire
Presence of other complications during catheter insertion
Time frame: Assessed once immediately after exam on patient questionnaire
Presence of complications during test recording
Time frame: Assessed once immediately after exam on patient questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Saline spray and Lidocaine Hydrochloride in people with Pain, Acute, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of pain during catheter insertion (time frame: Assessed once immediately after exam on patient questionnaire). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.