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

NCT01350024 | Completed DMC

• 1 other identifier: 20100631
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Blepharoptosis

Keywords

Conjunctival Mullerectomy; Blepharoptosis; Ptosis surgery; Pain Control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Efficacy of ptosis surgery

  2 months

• Pain Control

  1 hour after surgery

Study Arms (2)

Frontal Nerve Block

ACTIVE COMPARATOR

Patients will receive a frontal nerve block for anesthesia

Procedure: Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine

Subconjucntival Injection

ACTIVE COMPARATOR

Patients will receive a subconjunctival injection for anesthesia

Procedure: Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine

Interventions

Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine PROCEDURE

Frontal Nerve Block 5 cc will be administered preoperatively once.

Frontal Nerve Block

Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine PROCEDURE

Patients will receive a 1.5 cc dose of subconjunctival lidocaine as above

Subconjucntival Injection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• Patient with ptosis that requires correction
• Patient is able to consent for themselves

You may not qualify if:

• Patient unable to complete survey
• Patient had prior lid surgery
• Patient taking chronic pain medication

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Blepharoptosis; Agnosia

Interventions

Lidocaine; Indicator Dilution Techniques; Epinephrine

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Investigative Techniques; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Professor of Clinical

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: May 9, 2011
• Study Start: May 1, 2011
• Primary Completion: July 30, 2016
• Study Completion: July 30, 2016
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

US (1)