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Saline Injection - Assisted Anesthesia in Eyelid Surgery

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ClinicalTrials.gov Identifier: NCT01239498
Recruitment Status : Unknown
Verified August 2011 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : November 11, 2010
Last Update Posted : August 9, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The investigators hypothesize that injection of saline to the upper eyelids prior to lidocaine/adrenaline injection will reduce pain of the local anesthetic in comparison to injection of lidocaine alone.

Condition or disease Intervention/treatment Phase
Blepharoptosis Procedure: Injection of Saline + Lidocaine/Adrenaline Procedure: Lidocaine/Adrenaline only Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Saline Injection - Assisted Anesthesia in Eyelid Surgery
Study Start Date : November 2010
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : December 2011


Arms and Interventions

Arm Intervention/treatment
Experimental: Saline + Lidocaine/Adrenaline Procedure: Injection of Saline + Lidocaine/Adrenaline

All anaesthetic injections will consist of xylocaine 1% with 1:100,000 adrenaline and will be administered through a short 30 Gauge needle at a constant slow speed at multiple (6-7) sites along the upper lid by a single oculoplastic consultant.

The experimental eyelid will receive a saline-consisted injection 0.5cc prior to the administration of the anesthetic injection.

Injection of Saline + Lidocaine 1%

Other Name: Local eyelid anesthesia
Placebo Comparator: Lidocaine/Adrenaline only Procedure: Lidocaine/Adrenaline only
Injection of Lidocaine/Adrenaline only
Other Name: Local eyelid anesthesia


Outcome Measures

Primary Outcome Measures :
  1. Patients' verbal pain scores will be elicited and documented immediately by the oculoplastic fellow [ Time Frame: 1-2 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients undergoing bilateral upper eyelid surgery under local anaesthetic who have given fully informed consent to be in the trial

Exclusion Criteria:

  • Previous upper eyelid surgery
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239498


Contacts
Contact: Ido Didi Fabian, MD +972547830444 didifabian@gmail.com

Locations
Israel
Goldschlager eye institute Recruiting
Ramat Gan, Israel
Contact: Ido Ido Fabian, MD       didifabian@gmail.com   
Goldschleger institute of ophthalmology, Sheba medical center Not yet recruiting
Ramat Gan, Israel
Contact: Ido Didi Fabian, MD    +972547830444    didifabian@gmail.com   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Chair: Ido Didi Fabian, MD Sheba medical center, Goldschleger institute
More Information

Publications:
Responsible Party: Ido Didi Fabian MD, Sheba medical center
ClinicalTrials.gov Identifier: NCT01239498     History of Changes
Other Study ID Numbers: SHEBA-10-8246-DF-CTIL
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: August 9, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Blepharoptosis
Eyelid Diseases
Eye Diseases
Anesthetics
Lidocaine
Epinephrine
Racepinephrine
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents