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

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

Tracking Information

• First Submitted Date: May 5, 2011
• First Posted Date: May 9, 2011
• Last Update Posted Date: May 30, 2017
• Actual Study Start Date: May 1, 2011
• Actual Primary Completion Date: July 30, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Blepharoptosis

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 24, 2017): 34
• Original Estimated Enrollment (submitted: May 6, 2011): 50
• Actual Study Completion Date: July 30, 2016
• Actual Primary Completion Date: July 30, 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01350024
• Other Study ID Numbers: 20100631
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Wendy Lee, University of Miami
• Study Sponsor: University of Miami
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Miami
• Verification Date: May 2017