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

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.

Study Overview

• Status: Completed
• Conditions: Application Site Discomfort
• Intervention / Treatment: Drug: Bupivacaine lozenge; Drug: Xylocain, cutaneous spray, solution

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Kirurgisk Klinik Hvidovre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine lozenge; The patients will either get lidocaine spray or bupivacaine lozenge as an anaesthetic drug before the upper gastroscopic endoscopy.	Drug: Bupivacaine lozenge; 25 mg bupivacaine/lozenge. The patient will get one lozenge 10-15 minutes before the examination.
Active Comparator: Xylocain, cutaneous spray, solution; The patients will either get lidocaine spray or bupivacaine lozenge as an anaesthetic drug before the upper gastroscopic endoscopy.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Endoscopist evaluation on a 4 point scale.	The endoscopist evaluate the difficulty of the upper gastrointestinal endoscopy on a 4 point scale.	Day 1

Collaborators and Investigators

• Sponsor: Ove Andersen
• Collaborators: Oracain II Aps
• Investigators: Principal Investigator: Kaare Nielsen, MD, Kirurgisk Klinik Hvidovre

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: January 4, 2013
• First Submitted That Met QC Criteria: April 12, 2013
• First Posted (Estimate): April 16, 2013

Study Record Updates

• Last Update Posted (Estimate): April 16, 2013
• Last Update Submitted That Met QC Criteria: April 12, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Endoscopy; Lidocaine; Bupivacaine; Anesthetics, Local
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2011-0056-22-21