Saline Injection - Assisted Anesthesia in Eyelid Surgery

This study is currently recruiting participants.

Verified August 2011 by Sheba Medical Center

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

History of Changes

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:

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 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

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

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:

Chen BK, Eichenfield LF. Pediatric anesthesia in dermatologic surgery: when hand-holding is not enough. Dermatol Surg. 2001 Dec;27(12):1010-8. Review.

Brogan GX Jr, Giarrusso E, Hollander JE, Cassara G, Maranga MC, Thode HC. Comparison of plain, warmed, and buffered lidocaine for anesthesia of traumatic wounds. Ann Emerg Med. 1995 Aug;26(2):121-5.

Bainbridge LC. Comparison of room temperature and body temperature local anaesthetic solutions. Br J Plast Surg. 1991 Feb-Mar;44(2):147-8.

Stewart JH, Cole GW, Klein JA. Neutralized lidocaine with epinephrine for local anesthesia. J Dermatol Surg Oncol. 1989 Oct;15(10):1081-3.

Bartfield JM, Gennis P, Barbera J, Breuer B, Gallagher EJ. Buffered versus plain lidocaine as a local anesthetic for simple laceration repair. Ann Emerg Med. 1990 Dec;19(12):1387-9.

Fayers T, Morris DS, Dolman PJ. Vibration-assisted anesthesia in eyelid surgery. Ophthalmology. 2010 Jul;117(7):1453-7. Epub 2010 Mar 19.

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
Epinephryl borate
Lidocaine
Anesthetics
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents

Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Central Nervous System Depressants
Central Nervous System Agents
Anesthetics, Local
Sensory System Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on May 21, 2013

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