Trial record 3 of 4 for:    Open Studies | "Blepharoptosis"

Saline Injection - Assisted Anesthesia in Eyelid Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01239498
First received: November 2, 2010
Last updated: August 7, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Blepharoptosis
Procedure: Injection of Saline + Lidocaine/Adrenaline
Procedure: Lidocaine/Adrenaline only
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Saline Injection - Assisted Anesthesia in Eyelid Surgery

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Patients' verbal pain scores will be elicited and documented immediately by the oculoplastic fellow [ Time Frame: 1-2 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01239498

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

Locations
Israel
Goldschleger institute of ophthalmology, Sheba medical center Not yet recruiting
Ramat Gan, Israel
Contact: Ido Didi Fabian, MD    +972547830444    didifabian@gmail.com   
Goldschlager eye institute Recruiting
Ramat Gan, Israel
Contact: Ido Ido Fabian, MD       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
Study First Received: November 2, 2010
Last Updated: August 7, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Blepharoptosis
Eyelid Diseases
Eye Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Lidocaine
Anesthetics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Central Nervous System Depressants
Central Nervous System Agents
Anesthetics, Local
Sensory System Agents

ClinicalTrials.gov processed this record on August 27, 2014