NCT01239498

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 9, 2011

Status Verified

August 1, 2011

Enrollment Period

11 months

First QC Date

November 2, 2010

Last Update Submit

August 7, 2011

Conditions

Blepharoptosis

Outcome Measures

Primary Outcomes (1)

  • Patients' verbal pain scores will be elicited and documented immediately by the oculoplastic fellow

    1-2 minutes

Study Arms (2)

Saline + Lidocaine/Adrenaline

EXPERIMENTAL
Procedure: Injection of Saline + Lidocaine/Adrenaline

Lidocaine/Adrenaline only

PLACEBO COMPARATOR
Procedure: Lidocaine/Adrenaline only

Interventions

Injection of Saline + Lidocaine/AdrenalinePROCEDURE

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%

Also known as: Local eyelid anesthesia
Saline + Lidocaine/Adrenaline
Lidocaine/Adrenaline onlyPROCEDURE

Injection of Lidocaine/Adrenaline only

Also known as: Local eyelid anesthesia
Lidocaine/Adrenaline only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous upper eyelid surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Goldschlager eye institute

Ramat Gan, Israel

RECRUITING

Goldschleger institute of ophthalmology, Sheba medical center

Ramat Gan, Israel

NOT YET RECRUITING

Related Publications (6)

  • Chen BK, Eichenfield LF. Pediatric anesthesia in dermatologic surgery: when hand-holding is not enough. Dermatol Surg. 2001 Dec;27(12):1010-8. doi: 10.1046/j.1524-4725.2001.01854.x.

    PMID: 11849262BACKGROUND

  • 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. doi: 10.1016/s0196-0644(95)70139-7.

    PMID: 7618771BACKGROUND

  • Bainbridge LC. Comparison of room temperature and body temperature local anaesthetic solutions. Br J Plast Surg. 1991 Feb-Mar;44(2):147-8. doi: 10.1016/0007-1226(91)90050-t.

    PMID: 2018901BACKGROUND

  • Stewart JH, Cole GW, Klein JA. Neutralized lidocaine with epinephrine for local anesthesia. J Dermatol Surg Oncol. 1989 Oct;15(10):1081-3. doi: 10.1111/j.1524-4725.1989.tb03127.x.

    PMID: 2794204BACKGROUND

  • 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. doi: 10.1016/s0196-0644(05)82603-4.

    PMID: 2240750BACKGROUND

  • Fayers T, Morris DS, Dolman PJ. Vibration-assisted anesthesia in eyelid surgery. Ophthalmology. 2010 Jul;117(7):1453-7. doi: 10.1016/j.ophtha.2009.11.025. Epub 2010 Mar 19.

    PMID: 20303597BACKGROUND

MeSH Terms

Conditions

Blepharoptosis

Interventions

LidocaineEpinephrine

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Ido Didi Fabian, MD

    Sheba medical center, Goldschleger institute

    STUDY CHAIR

Central Study Contacts

Ido Didi Fabian, MD

CONTACT

+972547830444didifabian@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 11, 2010

Study Start

November 1, 2010

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

August 9, 2011

Record last verified: 2011-08

Locations

IL(2)