Facial Block for Outpatient Rhinoplasty Analgesia (FABLORA)

Civil Hospices of Lyon

Status and phase: Unknown; Phase 3

Conditions: Outpatient Rhinoplasty

Treatments: Drug: Bilateral facial block after general anesthesia before surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01872728

2012-005831-97 (EudraCT Number)

2012.774

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

placebo for the realization of the facial block and morphine for intraoperative analgesia

Treatment:

Drug: Bilateral facial block after general anesthesia before surgery

Levobupivacaine

Active Comparator group

Description:

Levobupivacaine for the realization of the facial block and placebo for intraoperative analgesia

Treatment:

Drug: Bilateral facial block after general anesthesia before surgery