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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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ClinicalTrials.gov Identifier: NCT01350024
Recruitment Status : Completed
First Posted : May 9, 2011
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Wendy Lee, University of Miami

Study Description
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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.


Condition or disease Intervention/treatment Phase
Blepharoptosis Procedure: Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine Procedure: Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid
Actual Study Start Date : May 1, 2011
Actual Primary Completion Date : July 30, 2016
Actual Study Completion Date : July 30, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Lidocaine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Frontal Nerve Block
Patients will receive a frontal nerve block for anesthesia
 Procedure: Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine
Frontal Nerve Block 5 cc will be administered preoperatively once.
Active Comparator: Subconjucntival Injection
Patients will receive a subconjunctival injection for anesthesia
 Procedure: Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine
Patients will receive a 1.5 cc dose of subconjunctival lidocaine as above


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Efficacy of ptosis surgery [ Time Frame: 2 months ]
    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.

  2. Pain Control [ Time Frame: 1 hour after surgery ]
    completion of survey to assess pain after surgery has been completed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350024


Locations
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United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Dr. Wendy Lee, Assoc. Professor of Clinical, University of Miami
ClinicalTrials.gov Identifier: NCT01350024    
Other Study ID Numbers: 20100631
First Posted: May 9, 2011    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Keywords provided by Dr. Wendy Lee, University of Miami:
Conjunctival Mullerectomy
Blepharoptosis
Ptosis surgery
Pain Control
Additional relevant MeSH terms:
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Blepharoptosis
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Eyelid Diseases
Eye Diseases
Lidocaine
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents