Postoperative Analgesia Following Wisdom Teeth Removal: Ropivacaine Versus Placebo

Centre Hospitalier Universitaire de Nīmes100 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Third Molar Extraction

Interventions

Placebo injectionDRUG

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

Ropivacaine injectionDRUG

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

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, France

Outcomes

Primary Outcomes

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.

Time frame: 24 hours

Secondary Outcomes

Total peroperative consumption of remifentanil

µg/kg

Time frame: During surgery (approximately 30-50 minutes)

Total peroperative consumption of propofol

mg/kg

Time frame: During surgery (approximately 30-50 minutes)

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

score from 0 to 10

Time frame: Day 1

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

score from 0 to 10

Time frame: Day 4

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

score from 0 to 10

Time frame: 1 month

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

score from 0 to 10

Time frame: 3 months

Total morphine consumption

Time frame: Hospital discharge (on average on days 1 or 2)

Use of rescue pain medicine (yes/no)

Data from ClinicalTrials.gov

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