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

NCT01832675 | Completed Phase 2 DMC

• 1 other identifier: 2011-0056-22-21
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Application Site Discomfort

Keywords

Endoscopy; Anesthetics, Local; Bupivacaine; Lidocaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient evaluation of taste and texture on a 3 point scale. - The investigator's assessment of the study by answering the questionnaire.

  Day 1

• Endoscopist evaluation on a 4 point scale.

  Day 1

Study Arms (2)

Bupivacaine lozenge

ACTIVE COMPARATOR

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

Drug: Bupivacaine lozenge

Xylocain, cutaneous spray, solution

ACTIVE COMPARATOR

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

Drug: Xylocain, cutaneous spray, solution

Interventions

Xylocain, cutaneous spray, solution 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.

Xylocain, cutaneous spray, solution

Bupivacaine lozenge DRUG

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

Bupivacaine lozenge

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ove Andersen: lead
• Oracain II Aps: collaborator

Study Sites (1)

Kirurgisk Klinik Hvidovre

Hvidovre, 2650, Denmark

Location

MeSH Terms

Interventions

Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Kaare Nielsen, MD

  Kirurgisk Klinik Hvidovre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: April 16, 2013
• Study Start: March 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: January 1, 2013
• Last Updated: April 16, 2013

Record last verified: 2013-04

Locations

DK (1)