Facial Block for Outpatient Rhinoplasty Analgesia

Phase 3

• Conditions: Outpatient Rhinoplasty
• Interventions: Drug: Bilateral facial block after general anesthesia before surgery

• Registration Number: NCT01872728
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-05
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-07
• Primary Completion: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-17
• Last Update Posted: 2014-03-18
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Bilateral facial block after general anesthesia before surgery	placebo for the realization of the facial block and morphine for intraoperative analgesia
Levobupivacaine	Bilateral facial block after general anesthesia before surgery	Levobupivacaine for the realization of the facial block and placebo for intraoperative analgesia

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Hôpital Edouard Herriot; 🇫🇷 Lyon, France