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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005831-97 | EudraCT Number |
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A bilateral facial block (infraorbital and infratrochlear) will be performed immediately after intubation in patients undergoing outpatient rhinoplasty with 2.5% levobupivacaine (intervention group) or saline as control. Intravenous saline or morphine will be administered at the end of surgery in intervention or control groups, respectively. In case of pain in post-anesthesia care unit (numerical pain score >3 on a 0-10 scale), both groups will receive intravenous morphine titration. The total perioperative morphine consumption (intraoperative and in post-anesthesia care unit) will be compared between groups. Pain intensity, presence of nausea/vomiting and patient's satisfaction will be compared between groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | placebo for the realization of the facial block and morphine for intraoperative analgesia |
|
| Levobupivacaine | Active Comparator | Levobupivacaine for the realization of the facial block and placebo for intraoperative analgesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral facial block after general anesthesia before surgery | Drug | Bilateral facial block (infraorbital and infratrochlear) after general anesthesia before surgery with intravenous placebo or bilateral block with placebo and intravenous morphine |
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine consumption during the perioperative period (operating theater and post-anesthesia care unit) | At the end of post-anesthesia care unit stay | J0 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity in post-anesthesia care unit | 0-10 numerical rating scale (NRS) : from 0 = no pain to 10 = worst pain imaginable | J0 (At arrival in post-operative care unit) |
| Postoperative nausea and vomiting |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Edouard Herriot | Lyon | France |
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Presence or absence of nausea/vomiting
| J1 (At day 1 after surgery) |
| Patient satisfaction at day 1 | 0-3 scale (0 = bad, 1 = poor, 2 = good, 3 = excellent) | J1 (At day 1 after surgery) |