Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT01541059
Eligibility Criteria:
Inclusion Criteria:
* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 3 months of follow-up
* American Society of Anesthesiology (ASA) score of 1, 2 or 3
* Patient programmed for surgical removal of all 4 wisdom teeth, excluding all other teeth, under general anesthesia
Exclusion Criteria:
* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is over 18 years old and under judicial protection, under tutorship or curatorship
* The patient (or legal representative)refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* Ineffective contraceptive
* Addiction or chronic pain treated with morphine
* Contra-indication for regional anesthesia (eg congenital or acquired coagulopathy, infection, allergy)
* Contra-indication to local anesthetics, general anesthetics and analgesics used in the protocol.
* Difficult cooperation, psychiatric disorders that could interfere with assessments
* Hypersensitivity to ropivacaine or other local anesthetics with amide links
* Contra-indication for the use of NaCl 0.9%: all states of sodium and water retention (especially heart failure, edema and ascites syndrome associated with cirrhosis)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
65 Years
Study:
NCT01541059
Study Brief:
Protocol Section:
NCT01541059