Facial Block for Outpatient Rhinoplasty Analgesia (FABLORA)

March 17, 2014 updated by: Hospices Civils de Lyon

Efficacy of Facial Block for Outpatient Rhinoplasty Analgesia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France
        • Hopital Edouard Herriot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control
placebo for the realization of the facial block and morphine for intraoperative analgesia
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
ACTIVE_COMPARATOR: Levobupivacaine
Levobupivacaine for the realization of the facial block and placebo for intraoperative analgesia
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total morphine consumption during the perioperative period (operating theater and post-anesthesia care unit)
Time Frame: J0
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
Time Frame: J0 (At arrival in post-operative 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
Time Frame: J1 (At day 1 after surgery)
Presence or absence of nausea/vomiting
J1 (At day 1 after surgery)
Patient satisfaction at day 1
Time Frame: J1 (At day 1 after surgery)
0-3 scale (0 = bad, 1 = poor, 2 = good, 3 = excellent)
J1 (At day 1 after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

June 5, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (ESTIMATE)

June 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 17, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012.774
  • 2012-005831-97 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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