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

Blepharoptosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350024
• Other study ID #: 20100631
• Status: Completed
• Phase: N/A
• First received: May 5, 2011
• Last updated: May 24, 2017
• Start date: May 1, 2011
• Est. completion date: July 30, 2016

Study information

• Verified date: May 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 30, 2016
• Est. primary completion date: July 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Blepharoptosis
• Pain, Postoperative

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.
• 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

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain control	Patients will be asked to complete a survey regardning pain assessment twenty-four hours after completion of surgery.	24 hour after surgery
Secondary	Efficacy of ptosis surgery	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 months
Secondary	Pain Control	completion of survey to assess pain after surgery has been completed.	1 hour after surgery