Postoperative Analgesia Following Wisdom Teeth Removal: Ropivacaine Versus Placebo

NCT ID: NCT01541059

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-08-29

Brief 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.

Detailed 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

Conditions

Third Molar Extraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo injection

Intervention Type: DRUG

Injection of saline solution into the vestibular capsule of each tooth to be extracted.

Ropivacaine

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

Group Type: EXPERIMENTAL

Ropivacaine injection

Intervention Type: DRUG

Ropivacaine is injected into the vestibular capsule of each tooth to be extracted.

Interventions

Placebo injection

Injection of saline solution into the vestibular capsule of each tooth to be extracted.

Intervention Type: DRUG

Ropivacaine injection

Ropivacaine is injected into the vestibular capsule of each tooth to be extracted.

Intervention Type: DRUG

Other Intervention Names

Standard intervention; Saline solution; Experimental intervention.

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)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Ripart, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, France

Countries

France

References

Ghezal H, Bouvet S, Kabani S, Ripart J, Cuvillon P. Ropivacaine versus placebo on postoperative analgesia and chronic pain following third molar extraction: A Prospective Randomized Controlled Study. J Stomatol Oral Maxillofac Surg. 2020 Apr;121(2):113-117. doi: 10.1016/j.jormas.2019.07.005. Epub 2019 Jul 18.

Reference Type: RESULT

PMID: 31326593 (View on PubMed)

Other Identifiers

2011-004972-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LOCAL/2011/JR/HG-02

Identifier Type: -

Identifier Source: org_study_id