Application Site Discomfort Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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