Application Site DiscomfortPhase 2NCT01832675
Clinical Trial With Bupivacaine Lozenges as Local Anaesthesia Under Upper Gastrointestinal Endoscopy
A Phase 2 study testing Xylocain, cutaneous spray, solution and Bupivacaine lozenge in people with Application Site Discomfort, run by Ove Andersen at 1 site in Denmark.
Trial summary
In this project the investigators want to compare a new anaesthetic method during upper gastroscopic endoscopy, compared to the traditional used method in a private clinic. The new method is a lozenge containing bupivacaine, and the traditional method is a lidocaine spray. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Application Site Discomfort
- What is being tested?
- Xylocain, cutaneous spray, solution and Bupivacaine lozenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Jan 2013
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referral from personal doctor for the upper gastroscopic endoscopy
- Age between 18 and 80 year
- Able to speak, read and understand the danish language
- Must be informed orally and released a written consent and a signed authorization statement
Who cannot join
- Known allergy to bupivacaine or other local anesthetics of the amide type.
- Pregnancy - the patient will be asked if she uses sufficient contraception. When in doubt a pregnancy test will be performed.
- Breastfeeding
- Use of other medicine before the examination besides the experimental medicine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Bupivacaine Lozenge as Topical Anesthesia Compared to Lidocaine Pharyngeal Spray Before Upper Gastrointestinal Endoscopy in Unsedated Patients
In this project the investigators want to compare a new anaesthetic method during upper gastroscopic endoscopy, compared to the traditional used method in a private clinic. The new method is a lozenge containing bupivacaine, and the traditional method is a lidocaine spray.
Read the detailed description
The research group has previously conducted a clinical study with patients who underwent an UGE at the Department of Gastroenterology, Hvidovre University Hospital, Denmark, where the effect of a new lidocaine lozenge was compared to the lidocaine suspension that was used as standard treatment. The results showed that the lozenge increased the patient's acceptance of the gag reflexes, decreased the patient discomfort during UGE and thereby increased patient acceptance of the UGE. Furthermore, there was a significant improvement in assessment of taste and texture of the lozenge compared to the suspension. A study by Thanvi et al. has shown that it is difficult to obtain valid VAS scores when the patients are sedated, as it might cause amnesia and may impair the patient's ability to make an accurate assessment of the discomfort. Sedation were a limitation for the study conducted by the research group, because of impairment in the patients judgmental abilities. Furthermore a longer duration of the effect of the lozenge was requested. Therefore, the research group reformulated the lozenge and changed the active pharmaceutical ingredient (API) to bupivacaine. Bupivacaine is an amide as lidocaine, but has a longer anesthetic effect and is four times as potent as lidocaine. It would therefore be relevant to optimize the study design and perform a new clinical study with unsedated patients undergoing UGE, where the bupivacaine lozenge was tested.
The clinical study was performed in the private gastrointestinal (GI) clinic at Hvidovre, Denmark. Before the UGE was performed the patient was locally anesthetized in the pharynx with a lidocaine spray as a standard treatment.
The hypothesis was that a bupivacaine lozenge would reduce the patient experienced discomfort during UGE due to a better local anesthetic effect compared to lidocaine spray. Moreover it is hypothesized that the bupivacaine lozenge would be more patient friendly than the lidocaine spray because of a better taste masking according to lesser bitter taste and a pleasant mode of being anesthetized.
The aim of the study was to compare patient discomfort by two different local anesthetic methods. The standard treatment was a lidocaine pharyngeal spray and was compared to the experimental treatment a bupivacaine lozenge. The efficacy and acceptance of the treatments were also examined, as well as the taste of the anesthetics. Furthermore the patient's and endoscopist's assessment of the UGE was examined.
- Conditions
- Application Site Discomfort
- Being tested
- Xylocain, cutaneous spray, solution, Bupivacaine lozenge
- Keywords
- Endoscopy, Anesthetics, Local, Bupivacaine, Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylocain, cutaneous spray, solutionDrug
10 mg lidocaine/spray. The patient will be sprayed three times and get a maximal dose of 30 mg lidocaine just before the examination.
Bupivacaine lozengeDrug
25 mg bupivacaine/lozenge. The patient will get one lozenge 10-15 minutes before the examination.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine lozenge | Active comparator | The patients will either get lidocaine spray or bupivacaine lozenge as an anaesthetic drug before the upper gastroscopic endoscopy. Receives: Drug: Bupivacaine lozenge |
| Xylocain, cutaneous spray, solution | Active comparator | The patients will either get lidocaine spray or bupivacaine lozenge as an anaesthetic drug before the upper gastroscopic endoscopy. Receives: Drug: Xylocain, cutaneous spray, solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patient experienced discomfort assessed on the Visual Analog Scale
The patient experienced discomfort during a upper gastroscopic endoscopy when using bupivacaine lozenge instead of lidocaine spray assessed on the Visual Analog Scale
Measured: Day 1
Secondary outcomes (2)
Patient evaluation of taste and texture on a 3 point scale. - The investigator's assessment of the study by answering the questionnaire.
Patient evaluation of taste and texture of the lozenge or the spray on a 3 point scale.
Measured: Day 1
Endoscopist evaluation on a 4 point scale.
The endoscopist evaluate the difficulty of the upper gastrointestinal endoscopy on a 4 point scale.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Application Site DiscomfortStudies of the same condition, open and under way.
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ove Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- Oracain II Aps
- Responsible party
- Sponsor-investigator, Ove Andersen, Hvidovre University Hospital
- Investigators
- Kaare Nielsen, MD, Principal investigator, Kirurgisk Klinik Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832675
- Sponsor's protocol ID
- 2011-0056-22-21
- Status last verified
- Apr 2013
- First submitted
- 4 Jan 2013
- Last updated
- 16 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Bupivacaine Lozenge as Topical Anesthesia Compared to Lidocaine Pharyngeal Spray Before Upper Gastrointestinal Endoscopy in Unsedated Patients
- ClinicalTrials.gov ID
- NCT01832675
- Acronym / sponsor ID
- 2011-0056-22-21
- Conditions
- Application Site Discomfort
- Keywords
- Endoscopy, Anesthetics, Local, Bupivacaine, Lidocaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ove AndersenUniversity, hospital or other
- Collaborators
- Oracain II Aps
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 16 Apr 2013 (estimated)
- 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.
In this project the investigators want to compare a new anaesthetic method during upper gastroscopic endoscopy, compared to the traditional used method in a private clinic. The new method is a lozenge containing bupivacaine, and the traditional method is a lidocaine spray.
Detailed description
The research group has previously conducted a clinical study with patients who underwent an UGE at the Department of Gastroenterology, Hvidovre University Hospital, Denmark, where the effect of a new lidocaine lozenge was compared to the lidocaine suspension that was used as standard treatment. The results showed that the lozenge increased the patient's acceptance of the gag reflexes, decreased the patient discomfort during UGE and thereby increased patient acceptance of the UGE. Furthermore, there was a significant improvement in assessment of taste and texture of the lozenge compared to the suspension. A study by Thanvi et al. has shown that it is difficult to obtain valid VAS scores when the patients are sedated, as it might cause amnesia and may impair the patient's ability to make an accurate assessment of the discomfort. Sedation were a limitation for the study conducted by the research group, because of impairment in the patients judgmental abilities. Furthermore a longer duration of the effect of the lozenge was requested. Therefore, the research group reformulated the lozenge and changed the active pharmaceutical ingredient (API) to bupivacaine. Bupivacaine is an amide as lidocaine, but has a longer anesthetic effect and is four times as potent as lidocaine. It would therefore be relevant to optimize the study design and perform a new clinical study with unsedated patients undergoing UGE, where the bupivacaine lozenge was tested.
The clinical study was performed in the private gastrointestinal (GI) clinic at Hvidovre, Denmark. Before the UGE was performed the patient was locally anesthetized in the pharynx with a lidocaine spray as a standard treatment.
The hypothesis was that a bupivacaine lozenge would reduce the patient experienced discomfort during UGE due to a better local anesthetic effect compared to lidocaine spray. Moreover it is hypothesized that the bupivacaine lozenge would be more patient friendly than the lidocaine spray because of a better taste masking according to lesser bitter taste and a pleasant mode of being anesthetized.
The aim of the study was to compare patient discomfort by two different local anesthetic methods. The standard treatment was a lidocaine pharyngeal spray and was compared to the experimental treatment a bupivacaine lozenge. The efficacy and acceptance of the treatments were also examined, as well as the taste of the anesthetics. Furthermore the patient's and endoscopist's assessment of the UGE was examined.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine lozenge | Active comparator | Drug: Bupivacaine lozengeThe patients will either get lidocaine spray or bupivacaine lozenge as an anaesthetic drug before the upper gastroscopic endoscopy. |
| Xylocain, cutaneous spray, solution | Active comparator | Drug: Xylocain, cutaneous spray, solutionThe patients will either get lidocaine spray or bupivacaine lozenge as an anaesthetic drug before the upper gastroscopic endoscopy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Referral from personal doctor for the upper gastroscopic endoscopy
- Age between 18 and 80 year
- Able to speak, read and understand the danish language
- Must be informed orally and released a written consent and a signed authorization statement
Key exclusion criteria (4 listed)
- Known allergy to bupivacaine or other local anesthetics of the amide type.
- Pregnancy - the patient will be asked if she uses sufficient contraception. When in doubt a pregnancy test will be performed.
- Breastfeeding
- Use of other medicine before the examination besides the experimental medicine.
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 |
|---|---|---|
| Xylocain, cutaneous spray, solution10 mg lidocaine/spray. The patient will be sprayed three times and get a maximal dose of 30 mg lidocaine just before the examination. | Drug | Xylocain, cutaneous spray, solution |
| Bupivacaine lozenge25 mg bupivacaine/lozenge. The patient will get one lozenge 10-15 minutes before the examination. | Drug | Bupivacaine lozenge |
Primary outcome
The patient experienced discomfort assessed on the Visual Analog Scale
Time frame: Day 1
The patient experienced discomfort during a upper gastroscopic endoscopy when using bupivacaine lozenge instead of lidocaine spray assessed on the Visual Analog Scale
2 secondary outcomes
Patient evaluation of taste and texture on a 3 point scale. - The investigator's assessment of the study by answering the questionnaire.
Time frame: Day 1
Endoscopist evaluation on a 4 point scale.
Time frame: Day 1
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 16 Apr 2013.
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.
Kaare Nielsen, MD principal investigator
Kirurgisk Klinik Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xylocain, cutaneous spray, solution and Bupivacaine lozenge in people with Application Site Discomfort, run by Ove Andersen at 1 site in Denmark.
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 4 inclusion and 4 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 16 Apr 2013. 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 Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
The patient experienced discomfort assessed on the Visual Analog Scale (time frame: Day 1). 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 16 Apr 2013.