Facial Block for Outpatient Rhinoplasty Analgesia

NCT ID: NCT01872728

Last Updated: 2014-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Outpatient Rhinoplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control

placebo for the realization of the facial block and morphine for intraoperative analgesia

Group Type PLACEBO_COMPARATOR

Bilateral facial block after general anesthesia before surgery

Intervention Type DRUG

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

Levobupivacaine

Levobupivacaine for the realization of the facial block and placebo for intraoperative analgesia

Group Type ACTIVE_COMPARATOR

Bilateral facial block after general anesthesia before surgery

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Edouard Herriot

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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2012-005831-97

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2012.774

Identifier Type: -

Identifier Source: org_study_id

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