Postoperative Analgesia Following Wisdom Teeth Removal: Ropivacaine Versus Placebo

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this study is to demonstrate the superiority of local analgesia with ropivacaine versus placebo on postoperative pain during the first 24 hours following bilateral surgery of all four third molars under general anesthesia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes
• Treatments: Anesthetics; Ropivacaine

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)