A PHASE IIb STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ROPIVACAINE COMPARED TO ADRENALINE-LIDOCAINE TO REDUCE PAIN IN PATIENT UNDERGOING SURGERY FOR THIRD MOLAR TEETH EXTRACTION.

• Conditions: third molar theeth included needing surgical extraction; MedDRA version: 12.1Level: LLTClassification code 10044039Term: Tooth extraction NOS

• Registration Number: EUCTR2011-000535-86-BE
• Lead Sponsor: CHU AMBROISE PARE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-28
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

•Subject undergoing 3rd molar extraction (4 teeth) under generalised anaesthesia
•Age = 12 years
•Subject has given voluntary written informed consent
•Subject is in the investigator’s opinion, willing and able to comply with the protocol requirements
•Subject has an ASA scoring of I or II
•Subject has the following laboratory values at baseline:
-platelet count = 50x109/L
-PTT > 40 sec
•Male or female subject who is post-menopausal, surgically sterilized or willing to use an acceptable method of birth control for the duration of the study
•Subject is in the investigator’s opinion able to complete a visual analogue scale

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•History of parodontal pathology or local inflammation at site of teeth extraction
•Subject had major surgery within 4 weeks before enrolment
•Subject with myocardial infarction within 6 months prior enrolment or with NHYA (New York Heart Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
•Subject has another serious medical condition that could potentially interfere with the completion of treatment according to this protocol or that would impair toleranceto therapy or prolong recovery.
•Subject has an active systemic infection requiring treatment
•Female subject is pregnant or breast feeding
•Subject enrolled in another clinical trial and/or receiving an investigational agent that will contra-indicate the use of Ropivacaïne® or xylocaïne®. Subjects are allowed to simultaneously participate to non-investigational trials.
•Known allergy to Ropivacaïne® or xylocaïne® or other local anesthetics agents of the amide type
•Patients with ongoing history of epilepsy
•Chronic treatment with opioïds
•History of ongoing gastric ulcer
•History of ongoing intracardiac conduction block
•Administration of beta blockers

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified