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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Wendy Lee, University of Miami
ClinicalTrials.gov Identifier:
NCT01350024
First received: May 5, 2011
Last updated: May 24, 2017
Last verified: May 2017
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dr. Wendy Lee, University of Miami:

Primary Outcome Measures:
  • 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:
  • 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.

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


Enrollment: 34
Actual Study Start Date: May 1, 2011
Study Completion Date: July 30, 2016
Primary Completion Date: July 30, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350024

Locations
United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
  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
Study First Received: May 5, 2011
Last Updated: May 24, 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

ClinicalTrials.gov processed this record on July 26, 2017