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Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery

Primary Purpose

Retinal Detachment

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Triamcinolone Acetonide 40mg/mL
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Retinal Detachment focused on measuring Scleral Buckle, Triamcinolone Acetonide

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient must have rhegmatogenous retinal detachment and be scheduled to undergo scleral buckle surgery for correction

Exclusion Criteria:

  • Advanced Glaucoma
  • History of corticosteroid responsive elevation in IOP
  • Allergy to Triamcinolone Acetonide or other corticosteroids
  • Pre-existing chronic pain disorders
  • Herpes zoster
  • Prior corneal allograft
  • Allergy to local anesthetic or penicillin
  • Patients unable to consent on own behalf
  • Patients unable to communicate pain and nausea levels
  • Pregnancy
  • Incarceration

Sites / Locations

  • Vistar Eye CentersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Experimental (Triamcinolone Acetonide)

Arm Description

No additional drug given

receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation

Outcomes

Primary Outcome Measures

Post Operative Pain Day 1
11-point Numerical Rating Scale (0-10, 10 being highest level of pain)

Secondary Outcome Measures

Post Operative Pain Week 1
11-point Numerical Rating Scale (0-10, 10 being highest level of pain)
Post Operative Pain Month 6
11-point Numerical Rating Scale (0-10, 10 being highest level of pain)
Nausea/Vomiting Score Day 1
Standard 7-pt scale for nausea and vomiting (0-6, 6 being most nausea/vomiting)
Nausea/Vomiting Score Week 1
Standard 7-pt scale for nausea and vomiting (0-6, 6 being most nausea/vomiting)
Pain Medication Use Day 1
Pill-Count
Pain Medication Use Week 1
Pill-Count

Full Information

First Posted
January 5, 2021
Last Updated
February 15, 2022
Sponsor
Virginia Polytechnic Institute and State University
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1. Study Identification

Unique Protocol Identification Number
NCT04701593
Brief Title
Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery
Official Title
Using Intraoperative Triamcinolone Acetonide Irrigation to Reduce Post-Operative Pain From Scleral Buckle Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2020 (Actual)
Primary Completion Date
January 3, 2023 (Anticipated)
Study Completion Date
July 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Polytechnic Institute and State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
PURPOSE: Scleral buckle surgery is a widely used ophthalmic surgery for the correction of rhegmatogenous retinal detachment. Studies suggest that eye pain is a common and underestimated occurrence after scleral buckle surgery, but as of yet, there is no definitive management method for reducing pain following scleral buckle surgery. The investigators aim to control pain following scleral buckle surgery with sub-tenon's irrigation with triamcinolone acetonide at the time of surgery. Using a randomized prospective clinical study, the investigators test if this technique will reduce the pain, nausea/vomiting, and analgesic use caused by scleral buckle surgery. METHODS: Forty-eight patients undergoing scleral buckle surgery will be randomized into two groups. The experimental group receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation. The control group does not receive any triamcinolone irrigation. Pain scores are measured 1 day post-operatively via 11-pt numerical rating scale as the primary outcome. The nausea/vomiting score is measured 1 day post-operatively via standard 6-pt scale. Patients track pain medication use via pill count. Values will be measured again at 1-2-week and 6 months post-op.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
Keywords
Scleral Buckle, Triamcinolone Acetonide

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No additional drug given
Arm Title
Experimental (Triamcinolone Acetonide)
Arm Type
Experimental
Arm Description
receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide 40mg/mL
Other Intervention Name(s)
Kenalog
Intervention Description
Sub-tenon irrigation 1cc
Primary Outcome Measure Information:
Title
Post Operative Pain Day 1
Description
11-point Numerical Rating Scale (0-10, 10 being highest level of pain)
Time Frame
1 Day Post-Op
Secondary Outcome Measure Information:
Title
Post Operative Pain Week 1
Description
11-point Numerical Rating Scale (0-10, 10 being highest level of pain)
Time Frame
1 Week Post-Op
Title
Post Operative Pain Month 6
Description
11-point Numerical Rating Scale (0-10, 10 being highest level of pain)
Time Frame
6 Months Post-Op
Title
Nausea/Vomiting Score Day 1
Description
Standard 7-pt scale for nausea and vomiting (0-6, 6 being most nausea/vomiting)
Time Frame
1 Day Post-Op
Title
Nausea/Vomiting Score Week 1
Description
Standard 7-pt scale for nausea and vomiting (0-6, 6 being most nausea/vomiting)
Time Frame
1 Week Post-Op
Title
Pain Medication Use Day 1
Description
Pill-Count
Time Frame
1 Day Post-Op
Title
Pain Medication Use Week 1
Description
Pill-Count
Time Frame
1 Week Post-Op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must have rhegmatogenous retinal detachment and be scheduled to undergo scleral buckle surgery for correction Exclusion Criteria: Advanced Glaucoma History of corticosteroid responsive elevation in IOP Allergy to Triamcinolone Acetonide or other corticosteroids Pre-existing chronic pain disorders Herpes zoster Prior corneal allograft Allergy to local anesthetic or penicillin Patients unable to consent on own behalf Patients unable to communicate pain and nausea levels Pregnancy Incarceration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Parth R Vaidya
Phone
3363911953
Email
vaidpr14@vt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Vishak J John, MD
Phone
(336) 703-7429
Email
Vishakjohn@vistareye.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vishak J John, MD
Organizational Affiliation
Virginia Tech, Vistar Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vistar Eye Centers
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24019
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vishak J John, MD
Phone
336-703-7429
Email
Vishakjohn@vistareye.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery

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