NCT01541059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2015

Completed
Last Updated

November 19, 2025

Status Verified

October 1, 2015

Enrollment Period

3.2 years

First QC Date

February 20, 2012

Last Update Submit

November 17, 2025

Conditions

Third Molar Extraction

Keywords

Third molar extractionlocal anesthesiaropivacaine

Outcome Measures

Primary Outcomes (1)

  • 24 hour area under the curve for pain

    Pain is assessed via a numeric, verbal scale (0 to 10) at baseline and then at 1.5, 2, 3, 4, 6 and 24 hours after surgery. The area under the resulting curve is calculated.

    24 hours

Secondary Outcomes (26)

  • Total peroperative consumption of remifentanil

    During surgery (approximately 30-50 minutes)

  • Total peroperative consumption of propofol

    During surgery (approximately 30-50 minutes)

  • Post operative pain as measured by a verbal, numeric scale (0 to 10)

    Day 1

  • Post operative pain as measured by a verbal, numeric scale (0 to 10)

    Day 4

  • Post operative pain as measured by a verbal, numeric scale (0 to 10)

    1 month

  • +21 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo injection

Ropivacaine

EXPERIMENTAL

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

Drug: Ropivacaine injection

Interventions

Placebo injectionDRUG

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

Also known as: Standard intervention, Saline solution
Placebo
Ropivacaine injectionDRUG

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

Also known as: Experimental intervention.
Ropivacaine

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • The patient is participating in another 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

Related Publications (1)

  • 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.

    PMID: 31326593RESULT

MeSH Terms

Interventions

Saline SolutionRopivacaine

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jacques Ripart, MD PhD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2012

First Posted

February 29, 2012

Study Start

June 1, 2012

Primary Completion

August 29, 2015

Study Completion

August 29, 2015

Last Updated

November 19, 2025

Record last verified: 2015-10

Locations

FR(1)