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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2011 by Bascom Palmer Eye Institute.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Bascom Palmer Eye Institute

ClinicalTrials.gov Identifier:

NCT01350024

First received: May 5, 2011

Last updated: May 6, 2011

Last verified: May 2011

History of Changes

Purpose

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.

Condition	Intervention
Blepharoptosis	Procedure: Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine Procedure: Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

Drug Information available for: Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Lidocaine hydrochloride Lidocaine Racepinephrine hydrochloride Racepinephrine

U.S. FDA Resources

Further study details as provided by Bascom Palmer Eye Institute:

Primary Outcome Measures:

Pain control [ Time Frame: 24 hour after surgery ] [ Designated as safety issue: No ]
Patients will be asked to complete a survey regardning pain assessment twenty-four hours after completion of surgery.

Secondary Outcome Measures:

Efficacy of ptosis surgery [ Time Frame: 2 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
completion of survey to assess pain after surgery has been completed.


Estimated Enrollment:	50
Study Start Date:	May 2011
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Frontal Nerve Block Patients will receive a frontal nerve block for anesthesia	Procedure: Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine Frontal Nerve Block 5 cc will be administered preoperatively once.
Active Comparator: Subconjucntival Injection Patients will receive a subconjunctival injection for anesthesia	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

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350024

Contacts


Contact: Chad C Zatezalo, MD	305-326-6000 ext 6788	czatezalo@med.miami.edu
Contact: Wendy Lee, MD	305-325-6000 ext 6788	wlee@med.miami.edu

Locations


United States, Florida
Bascom Palmer Eye Institute	Recruiting
Miami, Florida, United States, 33136
Contact: Chad C Zatezalo, MD 305-326-6000 ext 6788 czatezalo@med.miami.edu
Contact: Wendy Lee, MD 305-326-6000 ext 6788 wlee@med.miami.edu
Principal Investigator: Wendy Lee, MD
Sub-Investigator: Chad C Zatezalo, MD

Sponsors and Collaborators

Bascom Palmer Eye Institute

More Information

No publications provided


Responsible Party:	Wendy Lee, MD, Bascom Palmer Eye Institute, University of Miami
ClinicalTrials.gov Identifier:	NCT01350024 History of Changes
Other Study ID Numbers:	20100631
Study First Received:	May 5, 2011
Last Updated:	May 6, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Bascom Palmer Eye Institute:


Conjunctival Mullerectomy Blepharoptosis Ptosis surgery Pain Control

Additional relevant MeSH terms:


Blepharoptosis Eye Diseases Eyelid Diseases Anesthetics Epinephrine Epinephryl borate Lidocaine Racepinephrine Adrenergic Agents Adrenergic Agonists Adrenergic alpha-Agonists Adrenergic beta-Agonists Anesthetics, Local Anti-Arrhythmia Agents Anti-Asthmatic Agents	Autonomic Agents Bronchodilator Agents Cardiovascular Agents Central Nervous System Agents Central Nervous System Depressants Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Mydriatics Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Respiratory System Agents Sensory System Agents Sodium Channel Blockers

ClinicalTrials.gov processed this record on February 27, 2015

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