Third Molar ExtractionPhase 4RopiMolNCT01541059
Postoperative Analgesia Following Wisdom Teeth Removal: Ropivacaine Versus Placebo
A Phase 4 study testing Ropivacaine injection in people with Third Molar Extraction, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Third Molar Extraction
- What is being tested?
- Ropivacaine injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to 29 Aug 2015
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesia in Third Molar Surgery Under General Anesthesia: Ropivacaine Versus Placebo
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.
Read the 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:
- 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
- Being tested
- Placebo injection, Ropivacaine injection
- Keywords
- Third molar extraction, local anesthesia, ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo injectionDrug
Also called Standard intervention, Saline solution
Injection of saline solution into the vestibular capsule of each tooth to be extracted.
Ropivacaine injectionDrug
Also called Experimental intervention.
Ropivacaine is injected into the vestibular capsule of each tooth to be extracted.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Ropivacaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (26)
Total peroperative consumption of remifentanil
µg/kg
Measured: During surgery (approximately 30-50 minutes)
Total peroperative consumption of propofol
mg/kg
Measured: During surgery (approximately 30-50 minutes)
Post operative pain as measured by a verbal, numeric scale (0 to 10)
score from 0 to 10
Measured: Day 1
Post operative pain as measured by a verbal, numeric scale (0 to 10)
score from 0 to 10
Measured: Day 4
Post operative pain as measured by a verbal, numeric scale (0 to 10)
score from 0 to 10
Measured: 1 month
Post operative pain as measured by a verbal, numeric scale (0 to 10)
score from 0 to 10
Measured: 3 months
Total morphine consumption
mg
Measured: Hospital discharge (on average on days 1 or 2)
Use of rescue pain medicine (yes/no)
Measured: Hospital discharge (on average on days 1 or 2)
Total in-hospital Tramadol consumption
mg
Measured: Hospital discharge (on average on days 1 or 2)
Total in-hospital paracetamol consumption
g
Measured: Hospital discharge (on average on days 1 or 2)
Total in-hospital ketoprofen consumption
mg
Measured: Hospital discharge (on average on days 1 or 2)
Time elapsed between release from post-surgical recovery room and first request for rescue medicine
minutes
Measured: Hospital discharge (on average on days 1 or 2)
Length of recovery room stay
Time elapsed between admittance and discharge from the post-surgical recovery room. (minutes)
Measured: Recovery room discharge (Day 1)
Length of hospital stay
Time elapsed between admittance to post-surgical recovery room and hospital discharge (hours)
Measured: Hospital discharge (on average on days 1 or 2)
presence/absence of complications
pruritus, nausea, vomiting, bleeding, anesthesia of the mouth, difficulty breathing, drowsiness, headache, sweating, palpitations, skin rash, difficult glutition, dysarthria
Measured: 6 hours
presence/absence of complications
pruritus, nausea, vomiting, bleeding, anesthesia of the mouth, difficulty breathing, drowsiness, headache, sweating, palpitations, skin rash, difficult glutition, dysarthria
Measured: day 1
presence/absence of complications
pruritus, nausea, vomiting, bleeding, anesthesia of the mouth, difficulty breathing, drowsiness, headache, sweating, palpitations, skin rash, difficult glutition, dysarthria
Measured: day 3
Paracetamol consumption at home
grams
Measured: Day 1
Paracetamol consumption at home
grams
Measured: Day 3
ketoprofen consumption at home
mg
Measured: Day 1
ketoprofen consumption at home
mg
Measured: Day 3
Tramadol consumption at home
mg
Measured: Day 1
Tramadol consumption at home
mg
Measured: Day 3
Patient satisfaction
Patient satisfaction is evaluated via a numeric verbal scale ranging from 0 to 10.
Measured: Day 3
Chronic pain evaluation (DN4)
standard DN4 score
Measured: 1 month
Chronic pain evaluation (DN4)
standard DN4 score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startJun 2012
- Primary completion29 Aug 2015
- Study completion29 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Third Molar ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Ripart, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541059
- Sponsor's protocol ID
- LOCAL/2011/JR/HG-02
- Other IDs
- 2011-004972-13
- Acronym
- RopiMol
- Status last verified
- Oct 2015
- First submitted
- 20 Feb 2012
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31326593