Clinical Trial With Bupivacaine Lozenges as Local Anaesthesia Under Upper Gastrointestinal Endoscopy

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832675
• Other study ID #: 2011-0056-22-21
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2013
• Last updated: April 12, 2013
• Start date: March 2012
• Est. completion date: January 2013

Study information

• Verified date: April 2013
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Application Site Discomfort

Intervention

Drug:
• Xylocain, cutaneous spray, solution
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 lozenge
25 mg bupivacaine/lozenge. The patient will get one lozenge 10-15 minutes before the examination.

Locations

Country	Name	City	State
Denmark	Kirurgisk Klinik Hvidovre	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Ove Andersen	Oracain II Aps

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1	No
Secondary	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.	Day 1	No
Secondary	Endoscopist evaluation on a 4 point scale.	The endoscopist evaluate the difficulty of the upper gastrointestinal endoscopy on a 4 point scale.	Day 1	No