Facial Block for Outpatient Rhinoplasty Analgesia

Efficacy of Facial Block for Outpatient Rhinoplasty Analgesia

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01872728

Acronym

FABLORA

Enrollment

Registered

2013-06-07

Start date

2013-06-30

Completion date

2014-12-31

Last updated

2014-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Outpatient Rhinoplasty

Keywords

facial block, levobupivacaine, regional anesthesia, rhinoplasty, outpatient

Brief summary

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.

Interventions

DRUGBilateral facial block after general anesthesia before surgery

Bilateral facial block (infraorbital and infratrochlear) after general anesthesia before surgery with intravenous placebo or bilateral block with placebo and intravenous morphine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Total morphine consumption during the perioperative period (operating theater and post-anesthesia care unit)	J0	At the end of post-anesthesia care unit stay

Secondary

Measure	Time frame	Description
Pain intensity in post-anesthesia care unit	J0 (At arrival in post-operative care unit)	0-10 numerical rating scale (NRS) : from 0 = no pain to 10 = worst pain imaginable
Postoperative nausea and vomiting	J1 (At day 1 after surgery)	Presence or absence of nausea/vomiting
Patient satisfaction at day 1	J1 (At day 1 after surgery)	0-3 scale (0 = bad, 1 = poor, 2 = good, 3 = excellent)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026