NCT01995045

Brief Summary

The aim of this study is to evaluate if patients receiving a steroid (triamcinolone acetonide) combined with local anesthesia and antibiotic following retina surgery have better postoperative pain control those receiving local anesthesia and antibiotic alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2012

Longer than P75 for phase_4

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

Study Start

First participant enrolled

July 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 16, 2017

Completed
Last Updated

March 21, 2017

Status Verified

February 1, 2017

Enrollment Period

3.4 years

First QC Date

November 10, 2013

Results QC Date

December 27, 2016

Last Update Submit

February 16, 2017

Conditions

Retinal DetachmentProliferative VitreoretinopathyRetinoschisis

Keywords

RetinaVitreoretinalSurgery

Outcome Measures

Primary Outcomes (1)

  • Mean Pain Score

    The mean pain score assessed by the Visual Analog Pain Scale ranging from 0-10; 10 being the worst possible pain.

    Post-Operative Day 1 (Up to 24 hours)

Secondary Outcomes (3)

  • Mean Acetaminophen Intake

    Post Surgery (Up to 24 hours)

  • Mean Hydrocodone Intake

    Post Surgery (Up to 24 hours)

  • Mean Oxycodone Intake

    Post Surgery (Up to 24 hours)

Study Arms (2)

Bupivicaine & Triamcinolone

EXPERIMENTAL

Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide

Drug: TriamcinoloneDrug: Bupivicaine Hydrochloride

Bupivicaine

ACTIVE COMPARATOR

Retrobulbar anesthesia with Bupivicaine Hydrochloride

Drug: Bupivicaine Hydrochloride

Interventions

TriamcinoloneDRUG

Retrobulbar anesthesia

Also known as: Kenalog, Triamcinolone Acetonide
Bupivicaine & Triamcinolone
Bupivicaine HydrochlorideDRUG

Retrobulbar anesthesia

Also known as: Marcaine
BupivicaineBupivicaine & Triamcinolone

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing vitreoretinal surgery at the Emory Eye Center Ambulatory Surgery Center and Emory University Hospital by retina attending faculty surgeons

You may not qualify if:

  • Unable to verbalize level of pain control
  • Pediatric patients (\<18 years old)
  • Glaucoma, ocular hypertension, or glaucoma suspects
  • Allergy to local anesthetic
  • Pre-existing chronic pain requiring narcotic pain medication
  • Drug addiction
  • Impaired periorbital sensation (history of herpes simplex, zoster, corneal graft)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Eye Center

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • Gioia L, Prandi E, Codnotti M, Casati A,et al Peribulbar anesthesia with either 0.75% ropivacaine or a 2% lidocaine and 0.5% bupivacaine mixture for vitreoretinal surgery: a double-blinded study. Anesth Analg(89: 739-742, 1999. Shende D, Sadhasivam S, Madan R. Effects of peribulbar bupivacaine as an adjunct to general anaesthesia on peri-operative outcome following retinal detachment surgery. Anaesthesia(55): 970-975, 2000. Morel J, Pascal J, Charier D, et al. Preoperative peribulbar block in patients undergoing retinal detachment surgery under general anesthesia: a randomized double-blind study. Anesth Analg (102): 1082-1087, 2006. Ghali AM, Btarny AM. The effect on outcome of peribulbar anesthesia in conjunction with general anesthesia for vitreoretinal surgery. Anaesthesia (65): 249-253, 2010. Chavan SB, Cummings EJ.

    BACKGROUND

MeSH Terms

Conditions

Retinal DetachmentVitreoretinopathy, ProliferativeRetinoschisis

Interventions

TriamcinoloneTriamcinolone AcetonideBupivacaine

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesRetinal Degeneration

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr. Timothy Olsen
Organization
Emory University
tolsen@emory.edu
404-778-4996

Study Officials

  • Timothy W Olsen, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 10, 2013

First Posted

November 26, 2013

Study Start

July 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 21, 2017

Results First Posted

February 16, 2017

Record last verified: 2017-02

Locations

US(1)