Assessing Current Peripheral Nerve Block Catheter Fixation and Dressing Strategies: An Equivalence Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Boston Children's Hospital
- Locations
- 2
- Primary Endpoint
- nerve block catheter dislodgement
Study Overview
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.
Detailed Description
Generally speaking, the goals of affixing and dressing a peripheral nerve block (PNB) catheter include preservation of the position and integrity of the catheter, the integrity of the skin, and avoidance of infection. In order to accomplish this, nerve block catheters at Boston Children's Hospital (BCH) are affixed to a patient's skin and dressed in a number of ways, usually based on provider preference.
Just as care providers routinely employ several combinations of tape, occlusive dressings and skin preparations to secure and protect intravenous catheters (all thought to be standard-of-care based on their frequency of use), so do the members of the regional service dress PNB catheters with various combinations of catheter anchors, Dermabond, Mastisol, and Tegaderms. The exact combinations are based on physician preference and/or habit, though all dressing schemes generally employ at minimum a standard catheter anchor (provided by the catheter manufacturer) and a Tegaderm, frequently with the addition of either Mastisol or Dermabond or both in combination. The four possible combinations in current use are:
- Catheter anchor and Tegaderm only; 2. catheter anchor, Mastisol and Tegaderm; 3. catheter anchor, Dermabond and Tegaderm; 4. catheter anchor, Mastisol, Dermabond and Tegaderm
As no formal record is kept of dressing type and/or components, there is no accurate way of quantifying the frequencies of these dressing types being employed much less whether certain dressing strategies historically have been more effective than others maintaining the integrity of the catheter and surrounding skin.
These variations in routine practice suggest that there is not agreement about the benefits of adding either Mastisol or Dermabond (or both) to a dressing scheme, especially given their potential liabilities which include skin irritation (Mastisol, anecdotal at BCH), expense (Dermabond, approximately $20/use) and time (a couple of minutes drying time for each of these added elements).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Roland Brusseau
Instructor
Boston Children's Hospital