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

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.

Study Overview

• Status: Completed
• Conditions: Third Molar Extraction
• Intervention / Treatment: Drug: Placebo injection; Drug: Ropivacaine injection

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes Cedex 09, Gard, France, 30029
      • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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; Injection of saline solution into the vestibular capsule of each tooth to be extracted.; Other Names: Saline solution; Standard intervention
Experimental: Ropivacaine; 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; Ropivacaine is injected into the vestibular capsule of each tooth to be extracted.; Other Names: Experimental intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total peroperative consumption of remifentanil	µg/kg	During surgery (approximately 30-50 minutes)
Total peroperative consumption of propofol	mg/kg	During surgery (approximately 30-50 minutes)
Post operative pain as measured by a verbal, numeric scale (0 to 10)	score from 0 to 10	Day 1
Post operative pain as measured by a verbal, numeric scale (0 to 10)	score from 0 to 10	Day 4
Post operative pain as measured by a verbal, numeric scale (0 to 10)	score from 0 to 10	1 month
Post operative pain as measured by a verbal, numeric scale (0 to 10)	score from 0 to 10	3 months
Total morphine consumption	mg	Hospital discharge (on average on days 1 or 2)
Use of rescue pain medicine (yes/no)		Hospital discharge (on average on days 1 or 2)
Total in-hospital Tramadol consumption	mg	Hospital discharge (on average on days 1 or 2)
Total in-hospital paracetamol consumption	g	Hospital discharge (on average on days 1 or 2)
Total in-hospital ketoprofen consumption	mg	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	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)	Recovery room discharge (Day 1)
Length of hospital stay	Time elapsed between admittance to post-surgical recovery room and hospital discharge (hours)	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	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	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	day 3
Paracetamol consumption at home	grams	Day 1
Paracetamol consumption at home	grams	Day 3
ketoprofen consumption at home	mg	Day 1
ketoprofen consumption at home	mg	Day 3
Tramadol consumption at home	mg	Day 1
Tramadol consumption at home	mg	Day 3
Patient satisfaction	Patient satisfaction is evaluated via a numeric verbal scale ranging from 0 to 10.	Day 3
Chronic pain evaluation (DN4)	standard DN4 score	1 month
Chronic pain evaluation (DN4)	standard DN4 score	3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: February 20, 2012
• First Submitted That Met QC Criteria: February 23, 2012
• First Posted (Estimate): February 29, 2012

Study Record Updates

• Last Update Posted (Estimate): October 22, 2015
• Last Update Submitted That Met QC Criteria: October 21, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: ropivacaine; local anesthesia; Third molar extraction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: LOCAL/2011/JR/HG-02; 2011-004972-13 (EudraCT Number)