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Regional Anesthesia MorbidityNCT02926521

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

A study testing 2-octyl cyanoacrylate and Gum Mastic in people with Regional Anesthesia Morbidity, run by Boston Children's Hospital at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Regional Anesthesia Morbidity
What is being tested?
2-octyl cyanoacrylate and Gum Mastic
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Dec 2021to Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Boston Children"S Hospital

    Boston, Massachusetts, 02118

Other trials in United States

About this study

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.

Read the 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:

  1. 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).

Mastisol is a waterproof, clear liquid adhesive that has largely replaced tincture of benzoin as part of occlusive dressings (for nerve block catheters, IVs, arterial and central lines) as it is reported to have a significantly lower risk for skin irritation (1). As such, Mastisol has essentially become a standard of care for skin fixation and dressing of numerous catheter types. Papers in both the adult and pediatric regional anesthesia literature cite the use of Mastisol as a routine component of catheter fixation and dressing as well (2-4). However, there is little data in the literature evaluating the efficaciousness of Mastisol insofar as reducing catheter leakage or dislodgement and hence justifying its continued use as a part of catheter dressings. One study on healthy adults demonstrated differential forces required to dislodge a taped IV catheter with or without Mastisol (64 ± 1 vs. 46 ± 2 Newtons) however there is no data about catheter dislodgement rates over time in a clinical setting (5). One case report in the pediatric literature proposes a theoretical benefit of Mastisol use insofar as preventing regional anesthesia catheter dislodgement, but it too provides no clinical data (6).

Dermabond is a cyanoacrylate tissue adhesive that forms a strong bond across apposed wound edges, allowing normal healing to occur below and serving as a barrier to bacterial infiltration of the wound. It has been marketed to replace sutures that are 5-0 or smaller in diameter for incisional or laceration repair. This adhesive has been shown to save time during wound repair, to provide a flexible water-resistant protective coating and to eliminate the need for suture removal. Like Mastisol, Dermabond has become a commonplace addition to PNB catheter dressings for securement and puncture/insertion site closure both at BCH and nationally. And again, like Mastisol, there is little available data regarding whether Dermabond use as a part of the dressing scheme makes any difference insofar as catheter dislodgment or prevention of infection. A case series of three patients has been reported as recently as 2003 that described inclusion of Dermabond as a technique offering a simple, alternative method to secure a catheter for a prolonged period of time yet offered no qualitative or quantitative outcomes data (7). Other, more invasive, methods to fasten catheters have been advocated as well, such as suturing, retrograde subcutaneous tunneling (8), and cutaneous sutures (9).

Providers at BCH and elsewhere do not so much disagree as to what is the correct dressing for a nerve block catheter might be as they simply do not have relevant data to guide their decision-making. The physicians at BCH and at other institutions are using that method they believe is best by incorporating their own personal experiences as well as those of other clinicians. All agree that the primary goals, or benefits, of a good dressing system would be effective catheter stabilization, prevention of catheter occlusion or leakage, keeping the site clean and dry, and avoidance of infection. To-date, however, nerve block catheter dressings have not been studied in any rigorous way that might evaluate the various techniques for such outcomes.

There is scant literature available on this topic generally, despite a dressing's presumed importance in maintaining the appropriate position of the nerve block catheter and tip for maximal efficacy. The literature, if it can be called that, is largely comprised of numerous YouTube videos describing dressing and securing methodologies for nerve catheters (10); however none have been reported as having been evaluated in any rigorous prospective or retrospective analysis. (Reference to this general category of YouTube videos is made here as they essentially are a source of, and reflect, the standard of care and as such indicate the relative lack of rigorous evaluation of catheter securing techniques currently available).

Therefore the investigators wish to study whether the addition of Mastisol, Dermabond or both to PNB catheter dressings here at BCH has any influence on outcomes such as catheter dislodgment or function, skin integrity, and avoidance of infection. As such, the investigators propose a prospective, randomized study of equivalence of dressing type with the hypothesis that there is no more than a 10% difference in the rate of catheter dislodgement (the primary endpoint) between the 4 commonly used dressing schemes for PNB catheters at BCH.

Being tested
2-octyl cyanoacrylate, Gum Mastic
Keywords
nerve block catheter, catheter fixation, catheter dressing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2-octyl cyanoacrylateDevice

    Also called Dermabond

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

  • Gum MasticDevice

    Also called Mastisol Liquid Adhesive

    Addition of gum mastic liquid adhesive to nerve catheter dressing

Study groups in NCT02926521
Study groupRoleWhat they receive
Dressing ANo interventionDressing A: a nerve block catheter affixed with Pajunk anchor and covered with Tegaderm.
Dressing BActive comparatorDressing B: a nerve block catheter affixed with Pajunk anchor, skin treated with gum mastic liquid adhesive (Mastisol), all covered with Tegaderm
Receives: Device: Gum Mastic
Dressing CActive comparatorDressing C: a nerve block catheter sealed with 2-octyl cyanoacrylate liquid adhesive (Dermabond), trailing catheter affixed with Pajunk anchor, all covered with Tegaderm
Receives: Device: 2-octyl cyanoacrylate
Dressing DActive comparatorDressing 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
Receives: Device: 2-octyl cyanoacrylate; Device: Gum Mastic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. nerve block catheter dislodgement

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

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

Secondary outcomes (4)
  1. nerve block catheter occlusion

    presence or absence of catheter occlusion

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

  2. nerve block catheter leakage

    presence or absence of catheter leakage (presence of local anesthetic under occlusive dressing)

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

  3. skin irritation at site of nerve block catheter skin entry

    presence or absence of skin irritation (presence of hyperemic cutaneous reaction not present at dressing placement)

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

  4. catheter site infection

    presence or absence of catheter site infection (presence of purulent material)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2016 (estimated)
  2. Study start1 Dec 2021 (estimated)
  3. Primary completionJun 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Why it stopped: COVID 19 RELATED FACTORS

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02926521
Sponsor's protocol ID
IRB-P00021819
Status last verified
Jan 2022
First submitted
4 Oct 2016
Last updated
10 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 2-octyl cyanoacrylate and Gum Mastic in people with Regional Anesthesia Morbidity, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

nerve block catheter dislodgement (time frame: duration of catheter use, up to but not longer than, 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.

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