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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004972-13 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients in this arm will have standard anesthesia with the injection of placebo solution into the vestibular of each tooth to be extracted |
|
| Ropivacaine | Experimental | Patients in this arm will have general anesthesia with injection of ropivacaine into the vestibular next to each tooth to be extracted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo injection | Drug | Injection of saline solution into the vestibular capsule of each tooth to be extracted. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total peroperative consumption of remifentanil | µg/kg | During surgery (approximately 30-50 minutes) |
| Total peroperative consumption of propofol | mg/kg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques Ripart, MD PhD | Centre Hospitalier Universitaire de NÄ«mes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | Gard | 30029 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31326593 | Result | 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. |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Ropivacaine injection | Drug | Ropivacaine is injected into the vestibular capsule of each tooth to be extracted. |
|
|
| 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 |
| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |