Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 100 Years (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136

Sponsors and Collaborators

University of Miami

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr. Wendy Lee, Assoc. Professor of Clinical, University of Miami
ClinicalTrials.gov Identifier:	NCT01350024 History of Changes
Other Study ID Numbers:	20100631
First Posted:	May 9, 2011
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:

Pain, Postoperative; Blepharoptosis; Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Signs and Symptoms; Eyelid Diseases; Eye Diseases; Anesthetics; Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate

Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Local; 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