Facial Block for Outpatient Rhinoplasty Analgesia

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Facial Block for Outpatient Rhinoplasty Analgesia

Conditions
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Outpatient Rhinoplasty

Intervention / Treatment
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* Drug: Bilateral facial block after general anesthesia before surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient rhinoplasty American Society of Anesthesiologists (ASA) classification I-II Affiliated to Social Security Written informed consent Exclusion Criteria: Allergy to levobupivacaine Incapacity to give consent Chronic pain

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>placebo for the realization of the facial block and morphine for intraoperative analgesia | Drug: Bilateral facial block after general anesthesia before surgery<br>* Bilateral facial block (infraorbital and infratrochlear) after general anesthesia before surgery with intravenous placebo or bilateral block with placebo and intravenous morphine<br>|
| Active Comparator: Levobupivacaine<br>Levobupivacaine for the realization of the facial block and placebo for intraoperative analgesia | Drug: Bilateral facial block after general anesthesia before surgery<br>* Bilateral facial block (infraorbital and infratrochlear) after general anesthesia before surgery with intravenous placebo or bilateral block with placebo and intravenous morphine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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facial block, levobupivacaine, regional anesthesia, rhinoplasty, outpatient