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

NCT ID: NCT01832675

Last Updated: 2013-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-01-31

Brief 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.

Conditions

Application Site Discomfort

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Bupivacaine lozenge

The patients will either get lidocaine spray or bupivacaine lozenge as an anaesthetic drug before the upper gastroscopic endoscopy.

Group Type: ACTIVE_COMPARATOR

Bupivacaine lozenge

Intervention Type: DRUG

25 mg bupivacaine/lozenge. The patient will get one lozenge 10-15 minutes before the examination.

Xylocain, cutaneous spray, solution

The patients will either get lidocaine spray or bupivacaine lozenge as an anaesthetic drug before the upper gastroscopic endoscopy.

Group Type: ACTIVE_COMPARATOR

Xylocain, cutaneous spray, solution

Intervention Type: DRUG

10 mg lidocaine/spray. The patient will be sprayed three times and get a maximal dose of 30 mg lidocaine just before the examination.

Interventions

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.

Intervention Type: DRUG

Bupivacaine lozenge

25 mg bupivacaine/lozenge. The patient will get one lozenge 10-15 minutes before the examination.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oracain II Aps

UNKNOWN

Sponsor Role: collaborator

Ove Andersen

OTHER

Sponsor Role: lead

Responsible Party

Ove Andersen

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kaare Nielsen, MD

Role: PRINCIPAL_INVESTIGATOR

Kirurgisk Klinik Hvidovre

Locations

Kirurgisk Klinik Hvidovre

Hvidovre, , Denmark

Countries

Denmark

Other Identifiers

2011-0056-22-21

Identifier Type: -

Identifier Source: org_study_id