Postoperative Analgesia Following Wisdom Teeth Removal: Ropivacaine Versus Placebo

Third Molar Extraction Clinical Trial

— RopiMol  

Official title:

Postoperative Analgesia in Third Molar Surgery Under General Anesthesia: Ropivacaine Versus Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541059
• Other study ID #: LOCAL/2011/JR/HG-02
• Secondary ID: 2011-004972-13
• Status: Completed
• Phase: Phase 4
• First received: February 20, 2012
• Last updated: October 21, 2015
• Start date: June 2012
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Third Molar Extraction

Intervention

Drug:
• Placebo injection
Injection of saline solution into the vestibular capsule of each tooth to be extracted.
• Ropivacaine injection
Ropivacaine is injected into the vestibular capsule of each tooth to be extracted.

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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