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.
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
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:
- 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.
- Conditions
- Regional Anesthesia Morbidity
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 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.
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)
nerve block catheter occlusion
presence or absence of catheter occlusion
Measured: duration of catheter use, up to but not longer than, 1 week
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
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
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.
- First posted6 Oct 2016 (estimated)
- Study start1 Dec 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: COVID 19 RELATED FACTORS
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roland Brusseau, Boston Children's Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Current Peripheral Nerve Block Catheter Fixation and Dressing Strategies: An Equivalence Study
- ClinicalTrials.gov ID
- NCT02926521
- Acronym / sponsor ID
- IRB-P00021819
- Conditions
- Regional Anesthesia Morbidity
- Keywords
- nerve block catheter, catheter fixation, catheter dressing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID 19 RELATED FACTORS
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dressing A | No intervention | –Dressing A: a nerve block catheter affixed with Pajunk anchor and covered with Tegaderm. |
| Dressing B | Active comparator | Device: Gum MasticDressing B: a nerve block catheter affixed with Pajunk anchor, skin treated with gum mastic liquid adhesive (Mastisol), all covered with Tegaderm |
| Dressing C | Active comparator | Device: 2-octyl cyanoacrylateDressing C: a nerve block catheter sealed with 2-octyl cyanoacrylate liquid adhesive (Dermabond), trailing catheter affixed with Pajunk anchor, all covered with Tegaderm |
| Dressing D | Active comparator | Device: 2-octyl cyanoacrylate, Device: Gum MasticDressing 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- all subjects who are 0-100 years of age who are scheduled to receive a PNB catheter of one of the following types:
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-octyl cyanoacrylateAlso: DermabondAddition of 2-octyl cyanoacrylate liquid adhesive to nerve catheter dressing | Device | Dressing C, Dressing D |
| Gum MasticAlso: Mastisol Liquid AdhesiveAddition of gum mastic liquid adhesive to nerve catheter dressing | Device | Dressing B, Dressing D |
Primary outcome
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)
4 secondary outcomes
nerve block catheter occlusion
Time frame: duration of catheter use, up to but not longer than, 1 week
nerve block catheter leakage
Time frame: duration of catheter use, up to but not longer than, 1 week
skin irritation at site of nerve block catheter skin entry
Time frame: duration of catheter use, up to but not longer than, 1 week
catheter site infection
Time frame: duration of catheter use, up to but not longer than, 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Regional Anesthesia Morbidity
Recruiting
Impact of Communication Delays on Anesthesia Response to Medical Emergencies and Ultrasound-Guided Regional Anesthesia
Regional Anesthesia, Regional Anesthesia Morbidity
Recruiting
Ketamine Versus Dexmedetomidine as an Adjuvant in Scalp Block in Supratentorial Brain Tumor Excision Surgeries
Regional Anesthesia Morbidity, Supratentorial Brain Tumor
Recruiting
Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy
Mastectomy; Lymphedema, Chronic Pain
Active, not recruitingObservational study
Retrospective Analysis of Pain After Nerve Block in Surgical Patients
Regional Anesthesia Morbidity, Acute Pain
Recruiting
Pericapsular Nerve Group (PENG) Block Combined With Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration for Postoperative Analgesia in Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial
Arthropathy of Hip, Hip Arthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.