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

Not Applicable

Completed

• Conditions: Blepharoptosis

• Registration Number: NCT01350024
• Lead Sponsor: University of Miami

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 available

Study Timeline

• Study Start: 2011-05-01
• Study First Submitted: 2011-05-05
• Study First Submitted QC: 2011-05-06
• Study First Posted: 2011-05-09
• Primary Completion: 2016-07-30
• Study Completion: 2016-07-30
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain control	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

Name	Time	Method
Pain Control	1 hour after surgery	completion of survey to assess pain after surgery has been completed.
Efficacy of ptosis surgery	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.

Trial Locations

Locations (1)

Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States