Postoperative Analgesia Following Wisdom Teeth Removal: Ropivacaine Versus Placebo
- Conditions
- Third Molar Extraction
- Interventions
- Drug: Placebo injection
- Registration Number
- NCT01541059
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo injection Patients in this arm will have standard anesthesia with the injection of placebo solution into the vestibular of each tooth to be extracted Ropivacaine Ropivacaine injection Patients in this arm will have general anesthesia with injection of ropivacaine into the vestibular next to each tooth to be extracted.
- Primary Outcome Measures
Name Time Method 24 hour area under the curve for pain 24 hours 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.
- Secondary Outcome Measures
Name Time Method Total in-hospital Tramadol consumption Hospital discharge (on average on days 1 or 2) mg
Total in-hospital paracetamol consumption Hospital discharge (on average on days 1 or 2) g
Total peroperative consumption of remifentanil During surgery (approximately 30-50 minutes) µg/kg
Total peroperative consumption of propofol During surgery (approximately 30-50 minutes) mg/kg
Post operative pain as measured by a verbal, numeric scale (0 to 10) 3 months score from 0 to 10
Total morphine consumption Hospital discharge (on average on days 1 or 2) mg
Use of rescue pain medicine (yes/no) Hospital discharge (on average on days 1 or 2) Total in-hospital ketoprofen consumption Hospital discharge (on average on days 1 or 2) mg
Time elapsed between release from post-surgical recovery room and first request for rescue medicine Hospital discharge (on average on days 1 or 2) minutes
Length of recovery room stay Recovery room discharge (Day 1) Time elapsed between admittance and discharge from the post-surgical recovery room. (minutes)
Length of hospital stay Hospital discharge (on average on days 1 or 2) Time elapsed between admittance to post-surgical recovery room and hospital discharge (hours)
presence/absence of complications day 3 pruritus, nausea, vomiting, bleeding, anesthesia of the mouth, difficulty breathing, drowsiness, headache, sweating, palpitations, skin rash, difficult glutition, dysarthria
Paracetamol consumption at home Day 3 grams
ketoprofen consumption at home Day 3 mg
Tramadol consumption at home Day 3 mg
Patient satisfaction Day 3 Patient satisfaction is evaluated via a numeric verbal scale ranging from 0 to 10.
Chronic pain evaluation (DN4) 3 months standard DN4 score
Trial Locations
- Locations (1)
CHU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, Gard, France