Back to resultsComparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid
Primary Purpose
Blepharoptosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional supportive care trial for Blepharoptosis focused on measuring Conjunctival Mullerectomy, Blepharoptosis, Ptosis surgery, Pain Control
Eligibility Criteria
Inclusion Criteria:
- 18 years of age and older
- Patient with ptosis that requires correction
- Patient is able to consent for themselves
Exclusion Criteria:
- Patient unable to complete survey
- Patient had prior lid surgery
- Patient taking chronic pain medication
Sites / Locations
- Bascom Palmer Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Frontal Nerve Block
Subconjucntival Injection
Arm Description
Patients will receive a frontal nerve block for anesthesia
Patients will receive a subconjunctival injection for anesthesia
Outcomes
Primary Outcome Measures
Pain control
Patients will be asked to complete a survey regardning pain assessment twenty-four hours after completion of surgery.
Secondary Outcome Measures
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.
Pain Control
completion of survey to assess pain after surgery has been completed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01350024
Brief Title
Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid
Official Title
Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2011 (Actual)
Primary Completion Date
July 30, 2016 (Actual)
Study Completion Date
July 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharoptosis
Keywords
Conjunctival Mullerectomy, Blepharoptosis, Ptosis surgery, Pain Control
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Frontal Nerve Block
Arm Type
Active Comparator
Arm Description
Patients will receive a frontal nerve block for anesthesia
Arm Title
Subconjucntival Injection
Arm Type
Active Comparator
Arm Description
Patients will receive a subconjunctival injection for anesthesia
Intervention Type
Procedure
Intervention Name(s)
Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine
Intervention Description
Frontal Nerve Block 5 cc will be administered preoperatively once.
Intervention Type
Procedure
Intervention Name(s)
Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine
Intervention Description
Patients will receive a 1.5 cc dose of subconjunctival lidocaine as above
Primary Outcome Measure Information:
Title
Pain control
Description
Patients will be asked to complete a survey regardning pain assessment twenty-four hours after completion of surgery.
Time Frame
24 hour after surgery
Secondary Outcome Measure Information:
Title
Efficacy of ptosis surgery
Description
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.
Time Frame
2 months
Title
Pain Control
Description
completion of survey to assess pain after surgery has been completed.
Time Frame
1 hour after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years of age and older
Patient with ptosis that requires correction
Patient is able to consent for themselves
Exclusion Criteria:
Patient unable to complete survey
Patient had prior lid surgery
Patient taking chronic pain medication
Facility Information:
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
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Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid
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