Postoperative Analgesia Following Wisdom Teeth Removal: Ropivacaine Versus Placebo (RopiMol)

Centre Hospitalier Universitaire de Nīmes

Status and phase: Completed; Phase 4

Conditions: Third Molar Extraction

Treatments: Drug: Ropivacaine injection; Drug: Placebo injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01541059

2011-004972-13 (EudraCT Number)

LOCAL/2011/JR/HG-02

Details and patient eligibility

About

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.

Full description

The secondary objectives of this study are to compare regional anesthesia by ropivacaine versus placebo for the bilateral resection of all four third molars under general anesthesia, in terms of:

A. intraoperative use of propofol and remifentanil B. postoperative pain (EVN) at different time points C. in-hospital analgesic consumption D. time to first rescue analgesic request E. time spent in the post interventional treatment room F. length of hospital stay G. side effects H. analgesic consumption at home I. analgesic consumption (total) J. patient satisfaction K. Chronic pain after surgery

Enrollment: 100 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Patients in this arm will have standard anesthesia with the injection of placebo solution into the vestibular of each tooth to be extracted

Treatment:

Drug: Placebo injection

Ropivacaine

Experimental group

Description:

Patients in this arm will have general anesthesia with injection of ropivacaine into the vestibular next to each tooth to be extracted.

Treatment:

Drug: Ropivacaine injection