Facial Block for Outpatient Rhinoplasty Analgesia

Outpatient Rhinoplasty Clinical Trial

— FABLORA  

Official title:

Efficacy of Facial Block for Outpatient Rhinoplasty Analgesia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01872728
• Other study ID #: 2012.774
• Secondary ID: 2012-005831-97
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 5, 2013
• Last updated: March 17, 2014
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2014
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Outpatient Rhinoplasty

Intervention

Drug:
• Bilateral 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

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption during the perioperative period (operating theater and post-anesthesia care unit)	At the end of post-anesthesia care unit stay	J0	No
Secondary	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)	No
Secondary	Postoperative nausea and vomiting	Presence or absence of nausea/vomiting	J1 (At day 1 after surgery)	No
Secondary	Patient satisfaction at day 1	0-3 scale (0 = bad, 1 = poor, 2 = good, 3 = excellent)	J1 (At day 1 after surgery)	No