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Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery

Sponsor
Virginia Polytechnic Institute and State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04701593
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
42
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Triamcinolone Acetonide 40mg/mL
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Using Intraoperative Triamcinolone Acetonide Irrigation to Reduce Post-Operative Pain From Scleral Buckle Surgery
Actual Study Start Date :
Jan 3, 2020
Anticipated Primary Completion Date :
Jan 3, 2023
Anticipated Study Completion Date :
Jul 3, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

No additional drug given
Experimental: Experimental (Triamcinolone Acetonide)

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

Drug: Triamcinolone Acetonide 40mg/mL
Sub-tenon irrigation 1cc
Other Names:
  • Kenalog

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Post Operative Pain Day 1 [1 Day Post-Op]

      11-point Numerical Rating Scale (0-10, 10 being highest level of pain)

    Secondary Outcome Measures

    1. Post Operative Pain Week 1 [1 Week Post-Op]

      11-point Numerical Rating Scale (0-10, 10 being highest level of pain)

    2. Post Operative Pain Month 6 [6 Months Post-Op]

      11-point Numerical Rating Scale (0-10, 10 being highest level of pain)

    3. Nausea/Vomiting Score Day 1 [1 Day Post-Op]

      Standard 7-pt scale for nausea and vomiting (0-6, 6 being most nausea/vomiting)

    4. Nausea/Vomiting Score Week 1 [1 Week Post-Op]

      Standard 7-pt scale for nausea and vomiting (0-6, 6 being most nausea/vomiting)

    5. Pain Medication Use Day 1 [1 Day Post-Op]

      Pill-Count

    6. Pain Medication Use Week 1 [1 Week Post-Op]

      Pill-Count

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vistar Eye Centers Roanoke Virginia United States 24019

    Sponsors and Collaborators

    • Virginia Polytechnic Institute and State University

    Investigators

    • Principal Investigator: Vishak J John, MD, Virginia Tech, Vistar Eye Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Virginia Polytechnic Institute and State University
    ClinicalTrials.gov Identifier:
    NCT04701593
    Other Study ID Numbers:
    • 19-377
    First Posted:
    Jan 8, 2021
    Last Update Posted:
    Feb 17, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Virginia Polytechnic Institute and State University
    Scleral Buckle
    Triamcinolone Acetonide
    Additional relevant MeSH terms:
    Retinal Detachment
    Triamcinolone
    Triamcinolone Acetonide
    Triamcinolone hexacetonide
    Triamcinolone diacetate

    Study Results

    No Results Posted as of Feb 17, 2022