Clinical trial NCT01541059: Postoperative Analgesia Following Wisdom Teeth Removal: Ropivacaine Versus Placebo
Official title: Postoperative Analgesia in Third Molar Surgery Under General Anesthesia: Ropivacaine Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Third Molar Extraction
Keywords: Third molar extraction
local anesthesia
ropivacaine
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-02-29
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: 24 hour area under the curve for pain
timeFrame: 24 hours
Secondary outcomes:
measure: Total peroperative consumption of remifentanil
timeFrame: During surgery (approximately 30-50 minutes)
measure: Total peroperative consumption of propofol
timeFrame: During surgery (approximately 30-50 minutes)
measure: Post operative pain as measured by a verbal, numeric scale (0 to 10)
timeFrame: Day 1
measure: Post operative pain as measured by a verbal, numeric scale (0 to 10)
timeFrame: Day 4
measure: Post operative pain as measured by a verbal, numeric scale (0 to 10)
timeFrame: 1 month
measure: Post operative pain as measured by a verbal, numeric scale (0 to 10)
timeFrame: 3 months
measure: Total morphine consumption
timeFrame: Hospital discharge (on average on days 1 or 2)
measure: Use of rescue pain medicine (yes/no)
timeFrame: Hospital discharge (on average on days 1 or 2)
measure: Total in-hospital Tramadol consumption
timeFrame: Hospital discharge (on average on days 1 or 2)
measure: Total in-hospital paracetamol consumption
timeFrame: Hospital discharge (on average on days 1 or 2)
measure: Total in-hospital ketoprofen consumption
timeFrame: Hospital discharge (on average on days 1 or 2)
measure: Time elapsed between release from post-surgical recovery room and first request for rescue medicine
timeFrame: Hospital discharge (on average on days 1 or 2)
measure: Length of recovery room stay
timeFrame: Recovery room discharge (Day 1)
measure: Length of hospital stay
timeFrame: Hospital discharge (on average on days 1 or 2)
measure: presence/absence of complications
timeFrame: 6 hours
measure: presence/absence of complications
timeFrame: day 1
measure: presence/absence of complications
timeFrame: day 3
measure: Paracetamol consumption at home
timeFrame: Day 1
measure: Paracetamol consumption at home
timeFrame: Day 3
measure: ketoprofen consumption at home
timeFrame: Day 1
measure: ketoprofen consumption at home
timeFrame: Day 3
measure: Tramadol consumption at home
timeFrame: Day 1
measure: Tramadol consumption at home
timeFrame: Day 3
measure: Patient satisfaction
timeFrame: Day 3
measure: Chronic pain evaluation (DN4)
timeFrame: 1 month
measure: Chronic pain evaluation (DN4)
timeFrame: 3 months
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jacques Ripart, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.