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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

Tracking Information
First Submitted Date  ICMJE May 5, 2011
First Posted Date  ICMJE May 9, 2011
Last Update Posted Date May 30, 2017
Actual Study Start Date  ICMJE May 1, 2011
Actual Primary Completion Date July 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid
Official Title  ICMJE Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Blepharoptosis
Intervention  ICMJE
  • Procedure: Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine
    Frontal Nerve Block 5 cc will be administered preoperatively once.
  • 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
Study Arms  ICMJE
  • Active Comparator: Frontal Nerve Block
    Patients will receive a frontal nerve block for anesthesia
    Intervention: Procedure: Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine
  • Active Comparator: Subconjucntival Injection
    Patients will receive a subconjunctival injection for anesthesia
    Intervention: Procedure: Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2017)
34
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2011)
50
Actual Study Completion Date  ICMJE July 30, 2016
Actual Primary Completion Date July 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01350024
Other Study ID Numbers  ICMJE 20100631
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Wendy Lee, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Miami
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP