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Facial Block for Outpatient Rhinoplasty Analgesia (FABLORA)

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ClinicalTrials.gov Identifier: NCT01872728
Recruitment Status : Unknown
Verified March 2014 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : June 7, 2013
Last Update Posted : March 18, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Outpatient Rhinoplasty Drug: Bilateral facial block after general anesthesia before surgery Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Facial Block for Outpatient Rhinoplasty Analgesia
Study Start Date : June 2013
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Postoperative nausea and vomiting [ Time Frame: J1 (At day 1 after surgery) ]
    Presence or absence of nausea/vomiting

  3. Patient satisfaction at day 1 [ Time Frame: J1 (At day 1 after surgery) ]
    0-3 scale (0 = bad, 1 = poor, 2 = good, 3 = excellent)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872728


Locations
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France
Hôpital Edouard Herriot
Lyon, France
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01872728     History of Changes
Other Study ID Numbers: 2012.774
2012-005831-97 ( EudraCT Number )
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014

Keywords provided by Hospices Civils de Lyon:
facial block
levobupivacaine
regional anesthesia
rhinoplasty
outpatient

Additional relevant MeSH terms:
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Anesthetics
Levobupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents