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Assessing Current Peripheral Nerve Block Catheter Fixation and Dressing Strategies: An Equivalence Study

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ClinicalTrials.gov Identifier: NCT02926521
Recruitment Status : Suspended (COVID 19 RELATED FACTORS)
First Posted : October 6, 2016
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Roland Brusseau, Boston Children's Hospital

Brief Summary:
The investigators' objective is to evaluate whether any of the various peripheral nerve block catheter dressing strategies currently employed by the Boston Children's Hospital Regional Anesthesia Service has any differential impact on specific outcome endpoints such as regional block catheter dislodgement, catheter occlusion, catheter leakage, skin irritation, and skin infection.

Condition or disease Intervention/treatment Phase
Regional Anesthesia Morbidity Device: 2-octyl cyanoacrylate Device: Gum Mastic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessing Current Peripheral Nerve Block Catheter Fixation and Dressing Strategies: An Equivalence Study
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Dermabond

Arm Intervention/treatment
No Intervention: Dressing A
Dressing A: a nerve block catheter affixed with Pajunk anchor and covered with Tegaderm.
Active Comparator: Dressing B
Dressing B: a nerve block catheter affixed with Pajunk anchor, skin treated with gum mastic liquid adhesive (Mastisol), all covered with Tegaderm
Device: Gum Mastic
Addition of gum mastic liquid adhesive to nerve catheter dressing
Other Name: Mastisol Liquid Adhesive

Active Comparator: Dressing C
Dressing C: a nerve block catheter sealed with 2-octyl cyanoacrylate liquid adhesive (Dermabond), trailing catheter affixed with Pajunk anchor, all covered with Tegaderm
Device: 2-octyl cyanoacrylate
Addition of 2-octyl cyanoacrylate liquid adhesive to nerve catheter dressing
Other Name: Dermabond

Active Comparator: Dressing D
Dressing D: a nerve block catheter sealed with 2-octyl cyanoacrylate (Dermabond), trailing catheter affixed with Pajunk anchor, skin treated with gum mastic liquid adhesive (Mastisol), all covered with Tegaderm
Device: 2-octyl cyanoacrylate
Addition of 2-octyl cyanoacrylate liquid adhesive to nerve catheter dressing
Other Name: Dermabond

Device: Gum Mastic
Addition of gum mastic liquid adhesive to nerve catheter dressing
Other Name: Mastisol Liquid Adhesive




Primary Outcome Measures :
  1. nerve block catheter dislodgement [ Time Frame: duration of catheter use, up to but not longer than, 1 week ]
    presence or absence of catheter dislodgement (catheter out or no longer in a clinically effective position)


Secondary Outcome Measures :
  1. nerve block catheter occlusion [ Time Frame: duration of catheter use, up to but not longer than, 1 week ]
    presence or absence of catheter occlusion

  2. nerve block catheter leakage [ Time Frame: duration of catheter use, up to but not longer than, 1 week ]
    presence or absence of catheter leakage (presence of local anesthetic under occlusive dressing)

  3. skin irritation at site of nerve block catheter skin entry [ Time Frame: duration of catheter use, up to but not longer than, 1 week ]
    presence or absence of skin irritation (presence of hyperemic cutaneous reaction not present at dressing placement)

  4. catheter site infection [ Time Frame: duration of catheter use, up to but not longer than, 1 week ]
    presence or absence of catheter site infection (presence of purulent material)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all subjects who are 0-100 years of age who are scheduled to receive a PNB catheter of one of the following types:

    • lumbar plexus
    • paravertebral
    • femoral
    • sciatic
    • brachial plexus (infraclavicular, supraclavicular and interscalene approach)
    • TAP (transversus abdominis plane)

Exclusion Criteria:

  • Exclusions would be any patient with a known contraindication to any of the dressing materials and/or any block catheter that must be tunneled for clinical reasons.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926521


Locations
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United States, Massachusetts
Boston Children"S Hospital
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Children's Hospital
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Responsible Party: Roland Brusseau, Instructor, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02926521    
Other Study ID Numbers: IRB-P00021819
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roland Brusseau, Boston Children's Hospital:
nerve block catheter
catheter fixation
catheter dressing