Emergence AgitationPhase 4NCT02751268
Effect of Infraorbital and Infratrochlear Nerve Block on Emergence Agitation in Patients Undergoing Septorhinoplasty
A Phase 4 study testing Normal Saline and Ropivacaine in people with Emergence Agitation and Pain, run by Armed Forces Hampyeong Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether bilateral infraorbital and infratrochlear nerve block in patients undergoing septorhinoplasty are effective in preventing emergence agitation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Emergence Agitation, Pain
- What is being tested?
- Normal Saline and Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Mar 2017
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Septorhinoplasty
- American Society of Anesthesiologists (ASA) classification I-II
- Written informed consent
Who cannot join
- ASA classification greater than III
- Allergy to ropivacaine
- Incapability to give consent
- Chronic pain
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Armed Forces Hampyeong Hospital
Geumgyeri, Haebo-myeon, Hampyeong-gun, Jeollanam-do, 57116
About this study
Official title: Effect of Infraorbital and Infratrochlear Nerve Block on Emergence Agitation in Patients Undergoing Septorhinoplasty: A Randomized Controlled Trial
The purpose of this study is to determine whether bilateral infraorbital and infratrochlear nerve block in patients undergoing septorhinoplasty are effective in preventing emergence agitation.
Read the detailed description
Emergence agitation is a postanesthetic phenomenon characterized as confusion, disorientation and violent behavior. Although its etiology is not well understood, risk factors associated with the condition include pain and ENT (ear, nose and throat) surgery. Bilateral infraorbital and infratrochlear nerve block in patients undergoing septorhinoplasty is effective in treating postoperative pain. The investigators have designed this study to evaluate the effect of infraorbital and infratrochlear nerve block on emergence agitation in patients undergoing septorhinoplasty.
- Conditions
- Emergence Agitation, Pain
- Being tested
- Normal Saline, Ropivacaine
- Keywords
- infraorbital nerve block, infratrochlear nerve block, septorhinoplasty, general anesthesia, postoperative analgesia
- Medical subject headings
- Emergence Delirium, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
Bilateral infraorbital and infratrochlear nerve block before general anesthesia with normal saline
RopivacaineDrug
Bilateral infraorbital and infratrochlear nerve block before general anesthesia with 0.5% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | placebo for the realization of infraorbital and infratrochlear block Receives: Drug: Normal Saline |
| Ropivacaine | Active comparator | ropivacaine for the realization of infraorbital and infratrochlear block Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence agitation
Emergence agitation is measured by Riker Sedation-Agitated Scale (RASS) and is defined as RASS=5-7
Measured: 2 hours after surgery
Secondary outcomes (2)
Pain intensity
0-10 numerical rating scale (NRS) : from 0 = no pain to 10 = worst pain imaginable
Measured: 2, 8, 24, 48 hours after surgery
Patient satisfaction
1-5 scale (1: very unsatisfactory, 2: rather unsatisfactory, 3: fair, 4: rather satisfactory, 5: very satisfactory)
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Hampyeong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoon Choi, Armed Forces Hampyeong Hospital
- Investigators
- Hoon Choi, M.D., Principal investigator, Armed Forces Hampyeong Hostpital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751268
- Sponsor's protocol ID
- AFMC-16028-IRB-16-021
- Status last verified
- Apr 2016
- First submitted
- 24 Apr 2016
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kim HJ, Kim DK, Kim HY, Kim JK, Choi SW. Risk factors of emergence agitation in adults undergoing general anesthesia for nasal surgery. Clin Exp Otorhinolaryngol. 2015 Mar;8(1):46-51. doi: 10.3342/ceo.2015.8.1.46. Epub 2015 Feb 3.
PubMed 25729495Boselli E, Bouvet L, Augris-Mathieu C, Begou G, Diot-Junique N, Rahali N, Vertu-Ciolino D, Gerard C, Pivot C, Disant F, Allaouchiche B. Infraorbital and infratrochlear nerve blocks combined with general anaesthesia for outpatient rhinoseptoplasty: A prospective randomised, double-blind, placebo-controlled study. Anaesth Crit Care Pain Med. 2016 Feb;35(1):31-36. doi: 10.1016/j.accpm.2015.09.002. Epub 2015 Nov 5.
PubMed 26549134
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Infraorbital and Infratrochlear Nerve Block on Emergence Agitation in Patients Undergoing Septorhinoplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02751268
- Acronym / sponsor ID
- AFMC-16028-IRB-16-021
- Conditions
- Emergence Agitation, Pain
- Keywords
- infraorbital nerve block, infratrochlear nerve block, septorhinoplasty, general anesthesia, postoperative analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Armed Forces Hampyeong HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 26 Apr 2016 (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.
The purpose of this study is to determine whether bilateral infraorbital and infratrochlear nerve block in patients undergoing septorhinoplasty are effective in preventing emergence agitation.
Detailed description
Emergence agitation is a postanesthetic phenomenon characterized as confusion, disorientation and violent behavior. Although its etiology is not well understood, risk factors associated with the condition include pain and ENT (ear, nose and throat) surgery. Bilateral infraorbital and infratrochlear nerve block in patients undergoing septorhinoplasty is effective in treating postoperative pain. The investigators have designed this study to evaluate the effect of infraorbital and infratrochlear nerve block on emergence agitation in patients undergoing septorhinoplasty.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Normal Salineplacebo for the realization of infraorbital and infratrochlear block |
| Ropivacaine | Active comparator | Drug: Ropivacaineropivacaine for the realization of infraorbital and infratrochlear block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Septorhinoplasty
- American Society of Anesthesiologists (ASA) classification I-II
- Written informed consent
Key exclusion criteria (5 listed)
- ASA classification greater than III
- Allergy to ropivacaine
- Incapability to give consent
- Chronic pain
- Coagulopathy
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 |
|---|---|---|
| Normal SalineBilateral infraorbital and infratrochlear nerve block before general anesthesia with normal saline | Drug | Control |
| RopivacaineBilateral infraorbital and infratrochlear nerve block before general anesthesia with 0.5% ropivacaine | Drug | Ropivacaine |
Primary outcome
Emergence agitation
Time frame: 2 hours after surgery
Emergence agitation is measured by Riker Sedation-Agitated Scale (RASS) and is defined as RASS=5-7
2 secondary outcomes
Pain intensity
Time frame: 2, 8, 24, 48 hours after surgery
Patient satisfaction
Time frame: 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Background: PubMed 25729495Kim HJ, Kim DK, Kim HY, Kim JK, Choi SW. Risk factors of emergence agitation in adults undergoing general anesthesia for nasal surgery. Clin Exp Otorhinolaryngol. 2015 Mar;8(1):46-51. doi: 10.3342/ceo.2015.8.1.46. Epub 2015 Feb 3.
- Background: PubMed 26549134Boselli E, Bouvet L, Augris-Mathieu C, Begou G, Diot-Junique N, Rahali N, Vertu-Ciolino D, Gerard C, Pivot C, Disant F, Allaouchiche B. Infraorbital and infratrochlear nerve blocks combined with general anaesthesia for outpatient rhinoseptoplasty: A prospective randomised, double-blind, placebo-controlled study. Anaesth Crit Care Pain Med. 2016 Feb;35(1):31-36. doi: 10.1016/j.accpm.2015.09.002. Epub 2015 Nov 5.
- Individual participant dataSharing planned: No
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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.
Hoon Choi, M.D. principal investigator
Armed Forces Hampyeong Hostpital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Normal Saline and Ropivacaine in people with Emergence Agitation and Pain, run by Armed Forces Hampyeong Hospital at 1 site in South Korea.
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 3 inclusion and 5 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 29 Apr 2016. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Emergence agitation (time frame: 2 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02751268, which also lists 2 linked publications.
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 29 Apr 2016.