BlepharoptosisNCT01350024
Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid
A study testing Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine and Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine in people with Blepharoptosis, run by University of Miami at 1 site in United States.
Trial summary
Conjunctival Mullerectomy is a well known procedure used to correct upper lid ptosis via a posterior approach. Patients who undergo this procedure are often given local anesthesia to alleviate intraoperative and postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Blepharoptosis
- What is being tested?
- Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine and Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2011to 30 Jul 2016
- Phase
- Interventional
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Patient with ptosis that requires correction
- Patient is able to consent for themselves
Who cannot join
- Patient unable to complete survey
- Patient had prior lid surgery
- Patient taking chronic pain medication
Trial locations and contacts
1 site in 1 country.
About this study
Conjunctival Mullerectomy is a well known procedure used to correct upper lid ptosis via a posterior approach. Patients who undergo this procedure are often given local anesthesia to alleviate intraoperative and postoperative pain. Local anesthesia can be given via frontal nerve block or subconjunctival injection combined with sedation in most cases. Both techniques are currently acceptable options for local anesthesia, however postoperative pain has not been systematically evaluated between these two techniques.
The investigators aim to compare intra-operative and postoperative pain with these two techniques in patients undergoing conjunctival Mullerectomy for ptosis repair. Patients will be randomized to receive local anesthesia via frontal nerve block or via subconjunctival injection. In addition, the investigators will measure the surgical outcomes of the ptosis surgery with standard measures.
- Conditions
- Blepharoptosis
- Being tested
- Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine, Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine
- Keywords
- Conjunctival Mullerectomy, Blepharoptosis, Ptosis surgery, Pain Control
- Medical subject headings
- Blepharoptosis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrineProcedure or surgery
Frontal Nerve Block 5 cc will be administered preoperatively once.
Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrineProcedure or surgery
Patients will receive a 1.5 cc dose of subconjunctival lidocaine as above
| Study group | Role | What they receive |
|---|---|---|
| Frontal Nerve Block | Active comparator | Patients will receive a frontal nerve block for anesthesia Receives: Procedure: Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine |
| Subconjucntival Injection | Active comparator | Patients will receive a subconjunctival injection for anesthesia Receives: Procedure: Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain control
Patients will be asked to complete a survey regardning pain assessment twenty-four hours after completion of surgery.
Measured: 24 hour after surgery
Secondary outcomes (2)
Efficacy of ptosis surgery
Standard measures include marginal reflex distanced, palpebral fissure and levator fucntion will be used to assess the efficacy of the ptosis surgery and compared to the type of anesthesia the patient was given.
Measured: 2 months
Pain Control
completion of survey to assess pain after surgery has been completed.
Measured: 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study start1 May 2011
- Primary completion30 Jul 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharoptosisStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Wendy Lee, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350024
- Sponsor's protocol ID
- 20100631
- Status last verified
- May 2017
- First submitted
- 5 May 2011
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid
- ClinicalTrials.gov ID
- NCT01350024
- Acronym / sponsor ID
- 20100631
- Conditions
- Blepharoptosis
- Keywords
- Conjunctival Mullerectomy, Blepharoptosis, Ptosis surgery, Pain Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 May 2011 (actual)
- Primary completion
- 30 Jul 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 9 May 2011 (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.
Conjunctival Mullerectomy is a well known procedure used to correct upper lid ptosis via a posterior approach. Patients who undergo this procedure are often given local anesthesia to alleviate intraoperative and postoperative pain. Local anesthesia can be given via frontal nerve block or subconjunctival injection combined with sedation in most cases. Both techniques are currently acceptable options for local anesthesia, however postoperative pain has not been systematically evaluated between these two techniques.
The investigators aim to compare intra-operative and postoperative pain with these two techniques in patients undergoing conjunctival Mullerectomy for ptosis repair. Patients will be randomized to receive local anesthesia via frontal nerve block or via subconjunctival injection. In addition, the investigators will measure the surgical outcomes of the ptosis surgery with standard measures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frontal Nerve Block | Active comparator | Procedure: Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrinePatients will receive a frontal nerve block for anesthesia |
| Subconjucntival Injection | Active comparator | Procedure: Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrinePatients will receive a subconjunctival injection for anesthesia |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and older
- Patient with ptosis that requires correction
- Patient is able to consent for themselves
Key exclusion criteria (3 listed)
- Patient unable to complete survey
- Patient had prior lid surgery
- Patient taking chronic pain medication
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 |
|---|---|---|
| Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrineFrontal Nerve Block 5 cc will be administered preoperatively once. | Procedure or surgery | Frontal Nerve Block |
| Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrinePatients will receive a 1.5 cc dose of subconjunctival lidocaine as above | Procedure or surgery | Subconjucntival Injection |
Primary outcome
Pain control
Time frame: 24 hour after surgery
Patients will be asked to complete a survey regardning pain assessment twenty-four hours after completion of surgery.
2 secondary outcomes
Efficacy of ptosis surgery
Time frame: 2 months
Pain Control
Time frame: 1 hour after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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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.
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 study testing Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine and Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine in people with Blepharoptosis, run by University of Miami at 1 site in United States.
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 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: finished, as of the sponsor's last update on 30 May 2017. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain control (time frame: 24 hour after surgery). 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 30 May 2017.