Clinical Trial With Bupivacaine Lozenges as Local Anaesthesia Under Upper Gastrointestinal Endoscopy
Condition: Application Site Discomfort
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): Xylocain, cutaneous spray, solution; Bupivacaine lozenge
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg lidocaine/spray. The patient will be sprayed three times and get a maximal dose of 30 mg lidocaine just before the examination.; 25 mg bupivacaine/lozenge. The patient will get one lozenge 10-15 minutes before the examination.
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Endoscopy; Anesthetics, Local; Bupivacaine; Lidocaine