Outpatient RhinoplastyPhase 3FABLORANCT01872728
Facial Block for Outpatient Rhinoplasty Analgesia
A Phase 3 study testing Bilateral facial block after general anesthesia before surgery in people with Outpatient Rhinoplasty, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Outpatient Rhinoplasty
- What is being tested?
- Bilateral facial block after general anesthesia before surgery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient rhinoplasty
- American Society of Anesthesiologists (ASA) classification I-II
- Affiliated to Social Security
- Written informed consent
Who cannot join
- Allergy to levobupivacaine
- Incapacity to give consent
- Chronic pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Outpatient Rhinoplasty
- Being tested
- Bilateral facial block after general anesthesia before surgery
- Keywords
- facial block, levobupivacaine, regional anesthesia, rhinoplasty, outpatient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral facial block after general anesthesia before surgeryDrug
Bilateral facial block (infraorbital and infratrochlear) after general anesthesia before surgery with intravenous placebo or bilateral block with placebo and intravenous morphine
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | placebo for the realization of the facial block and morphine for intraoperative analgesia Receives: Drug: Bilateral facial block after general anesthesia before surgery |
| Levobupivacaine | Active comparator | Levobupivacaine for the realization of the facial block and placebo for intraoperative analgesia Receives: Drug: Bilateral facial block after general anesthesia before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption during the perioperative period (operating theater and post-anesthesia care unit)
At the end of post-anesthesia care unit stay
Measured: J0
Secondary outcomes (3)
Pain intensity in post-anesthesia care unit
0-10 numerical rating scale (NRS) : from 0 = no pain to 10 = worst pain imaginable
Measured: J0 (At arrival in post-operative care unit)
Postoperative nausea and vomiting
Presence or absence of nausea/vomiting
Measured: J1 (At day 1 after surgery)
Patient satisfaction at day 1
0-3 scale (0 = bad, 1 = poor, 2 = good, 3 = excellent)
Measured: J1 (At day 1 after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outpatient RhinoplastyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872728
- Sponsor's protocol ID
- 2012.774
- Other IDs
- 2012-005831-97
- Acronym
- FABLORA
- Status last verified
- Mar 2014
- First submitted
- 5 Jun 2013
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Facial Block for Outpatient Rhinoplasty Analgesia
- ClinicalTrials.gov ID
- NCT01872728
- Acronym / sponsor ID
- FABLORA / 2012.774
- Conditions
- Outpatient Rhinoplasty
- Keywords
- facial block, levobupivacaine, regional anesthesia, rhinoplasty, outpatient
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Bilateral facial block after general anesthesia before surgeryplacebo for the realization of the facial block and morphine for intraoperative analgesia |
| Levobupivacaine | Active comparator | Drug: Bilateral facial block after general anesthesia before surgeryLevobupivacaine for the realization of the facial block and placebo for intraoperative analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatient rhinoplasty
- American Society of Anesthesiologists (ASA) classification I-II
- Affiliated to Social Security
- Written informed consent
Key exclusion criteria (3 listed)
- Allergy to levobupivacaine
- Incapacity to give consent
- Chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral facial block after general anesthesia before surgeryBilateral facial block (infraorbital and infratrochlear) after general anesthesia before surgery with intravenous placebo or bilateral block with placebo and intravenous morphine | Drug | Control, Levobupivacaine |
Primary outcome
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
3 secondary outcomes
Pain intensity in post-anesthesia care unit
Time frame: J0 (At arrival in post-operative care unit)
Postoperative nausea and vomiting
Time frame: J1 (At day 1 after surgery)
Patient satisfaction at day 1
Time frame: J1 (At day 1 after surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bilateral facial block after general anesthesia before surgery in people with Outpatient Rhinoplasty, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption during the perioperative period (operating theater and post-anesthesia care unit) (time frame: J0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014; AzTrials last refreshed its copy on 8 Nov 2026.