NCT01258959

Brief Summary

Ophthalmic surgery on the posterior section of the eye can either be performed under general anaesthesia or under local aneasthesia. The local anaesthesia is performed by injecting local anaesthetics behind the eye. There are two techniques: Either the needle is placed into the muscle cone formed by the four recti muscles - this is called intraconal or retrobulbar block, or the needle is placed outside of the muscle cone - this would be called extraconal or peribulbar. In our hospital the investigators usually perform the peribulbar block since it is easier to perform and has a smaller risk to injure the eye. The investigators however realize that the parabulbar block is sometimes very efficient and sometimes not, thus requiring a second or third injection. Now investigators are able to visualize where the local anaesthetics spreads with the help of ultrasound imaging. The aim of the study is to observe and to describe the incidence of intraconal spread of local anaesthetics when a peribulbar block is performed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 8, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 13, 2010

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 9, 2011

Status Verified

December 1, 2010

Enrollment Period

5 months

First QC Date

December 8, 2010

Last Update Submit

June 8, 2011

Conditions

Keywords

Ultrasound, retrobulbar, parabulbar, ophthalmic surgery.

Outcome Measures

Primary Outcomes (1)

  • Incidence of detectable retrobulbar spread of local anaesthetics during peribulbar injection.

    The outcome measure is the description of the spread of local anesthetics during the injection of the drug via the parabulbar needle.

    At start (During peribulbar injection)

Secondary Outcomes (1)

  • Assessment of block quality

    20 Minutes after block

Study Arms (1)

Ophthalmic surgery patients

Patients (men and women) of at least 18 years of age undergoing an ophthalmic procedure on the posterior section of the eye under local anaesthesia, i.e. with a peribulbar block. Inclusion and exclusion criteria for the study are the same as for the peribulbar anaesthesia.

Procedure: Ultrasound detection of local anesthetics spread

Interventions

During the parabulbar injection the ultrasound operator experienced in ultrasound guided retrobulbar block will assess whether there is spread of local anaesthetic in the central cone just behind the sclera (yes or no). The anaesthesist performing the block will be blinded to the ultrasound visualized spread of local anaesthetic.

Ophthalmic surgery patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

100 consecutive patients (men and women) of at least 18 years of age undergoing an ophthalmic procedure on the posterior section of the eye under local anaesthesia, i.e. with a peribulbar block.

You may qualify if:

  • informed consent

You may not qualify if:

  • coagulation disorder
  • INR over 1.5 and/or a platelet count less than 75 X 109/L,
  • pathological myopia,
  • inability of the patient to lie down for the operation for more than 2 hours
  • lack of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Science Centres

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (3)

  • Luyet C, Eichenberger U, Moriggl B, Remonda L, Greif R. Real-time visualization of ultrasound-guided retrobulbar blockade: an imaging study. Br J Anaesth. 2008 Dec;101(6):855-9. doi: 10.1093/bja/aen293. Epub 2008 Oct 23.

    PMID: 18948389BACKGROUND
  • Ripart J, Lefrant JY, de La Coussaye JE, Prat-Pradal D, Vivien B, Eledjam JJ. Peribulbar versus retrobulbar anesthesia for ophthalmic surgery: an anatomical comparison of extraconal and intraconal injections. Anesthesiology. 2001 Jan;94(1):56-62. doi: 10.1097/00000542-200101000-00013.

    PMID: 11135722BACKGROUND
  • Ropo A, Nikki P, Ruusuvaara P, Kivisaari L. Comparison of retrobulbar and periocular injections of lignocaine by computerised tomography. Br J Ophthalmol. 1991 Jul;75(7):417-20. doi: 10.1136/bjo.75.7.417.

    PMID: 1854695BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 8, 2010

First Posted

December 13, 2010

Study Start

January 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 9, 2011

Record last verified: 2010-12

Locations