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

NCT02926521 | Withdrawn

• 1 other identifier: IRB-P00021819
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia Morbidity

Keywords

nerve block catheter; catheter fixation; catheter dressing

Outcome Measures

Primary Outcomes (1)

• nerve block catheter dislodgement

  presence or absence of catheter dislodgement (catheter out or no longer in a clinically effective position)

  duration of catheter use, up to but not longer than, 1 week

Secondary Outcomes (4)

• nerve block catheter occlusion

  duration of catheter use, up to but not longer than, 1 week

• nerve block catheter leakage

  duration of catheter use, up to but not longer than, 1 week

• skin irritation at site of nerve block catheter skin entry

  duration of catheter use, up to but not longer than, 1 week

• catheter site infection

  duration of catheter use, up to but not longer than, 1 week

Study Arms (4)

Dressing A

NO INTERVENTION

Dressing A: a nerve block catheter affixed with Pajunk anchor and covered with Tegaderm.

Dressing B

ACTIVE COMPARATOR

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

Dressing C

ACTIVE COMPARATOR

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

Dressing D

ACTIVE COMPARATOR

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; Device: Gum Mastic

Interventions

2-octyl cyanoacrylate DEVICE

Addition of 2-octyl cyanoacrylate liquid adhesive to nerve catheter dressing

Also known as: Dermabond

Dressing C; Dressing D

Gum Mastic DEVICE

Addition of gum mastic liquid adhesive to nerve catheter dressing

Also known as: Mastisol Liquid Adhesive

Dressing B; Dressing D

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children"S Hospital

Boston, Massachusetts, 02118, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 6, 2016
• Study Start: December 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)