Regional Anesthesia MorbidityNCT03375190
A Comparison of Peripheral Nerve Catheter Securement Techniques at the Insertion Site in Healthy Volunteers
A study testing Dressing, Dressing + adhesive and Experimental: Dressing + adhesive + strips (parallel) in people with Regional Anesthesia Morbidity, run by Duke University at 1 site in United States.
Trial summary
Continuous peripheral nerve block catheters are used for prolonged analgesia, but are often associated with complications such as catheter failure or dislodgement. This is a single center, prospective study to compare peripheral nerve catheter securement techniques at the insertion site in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia Morbidity
- What is being tested?
- Dressing, Dressing + adhesive and Experimental: Dressing + adhesive + strips (parallel)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2018to 28 Feb 2018
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-85 years
- American Society of Anesthesiologists Physical Status I-II
- BMI 18-30 kg/m2
Who cannot join
- Inability to cooperate with or understand protocol
- Inability to understand or speak English
- Allergy to adhesive or tape
- Local infection in lower extremities
- Neurologic deficit or disorder
- Anticoagulation
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Continuous peripheral nerve block catheters are used for prolonged analgesia, but are often associated with complications such as catheter failure or dislodgement. This is a single center, prospective study to compare peripheral nerve catheter securement techniques at the insertion site in healthy volunteers.
Read the detailed description
This study will involve the placement of subcutaneous peripheral nerve catheters in healthy volunteers utilizing 6 different securement techniques. The primary outcome is the force required to dislodge the peripheral nerve catheter by 1 centimeter as measured by a dynamometer in Newtons. The secondary endpoint will be the force required to disrupt the catheter dressing.
- Conditions
- Regional Anesthesia Morbidity
- Being tested
- Dressing, Dressing + adhesive, Experimental: Dressing + adhesive + strips (parallel), Experimental: Dressing + adhesive + strips (perpend), Experimental: Dressing + adhesive + strips + benzoin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DressingOther
Transparent film dressing (TegadermTM CHG Chlorhexidine Gluconate IV Securement Dressing, 3M Health Care, St. Paul, MN, USA) alone
Dressing + adhesiveOther
Transparent film dressing + topical skin adhesive (SwiftSetTM Topical Skin Adhesive, CovidienTM Devon, UK) at insertion site
Experimental: Dressing + adhesive + strips (parallel)Other
Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed parallel to long axis of catheter
Experimental: Dressing + adhesive + strips (perpend)Other
Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed perpendicular to long axis of catheter
Experimental: Dressing + adhesive + strips + benzoinOther
Transparent film dressing + topical skin adhesive + skin closure strips + topical benzoin (Compound Tincture of Benzoin USP 10%, Professional Disposables International, Inc., Orangeburg, NY, USA) spread in a 12 centimeter by 14 centimeter area around the insertion site
Experimental: Dressing + adhesive + strips + sprayOther
Transparent film dressing + topical skin adhesive + skin closure strips + medical adhesive spray (AdaptTM Medical Adhesive, Hollister Incorporated, Libertyville, IL, USA) in a 12 centimeter by 14 centimeter area around the insertion site
| Study group | Role | What they receive |
|---|---|---|
| Dressing | Experimental | Transparent film dressing (TegadermTM CHG Chlorhexidine Gluconate IV Securement Dressing, 3M Health Care, St. Paul, MN, USA) alone Receives: Other: Dressing |
| Dressing + adhesive | Experimental | Transparent film dressing + topical skin adhesive (SwiftSetTM Topical Skin Adhesive, CovidienTM, Devon, UK) at insertion site Receives: Other: Dressing + adhesive |
| Dressing + adhesive + strips (parallel) | Experimental | Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed parallel to long axis of catheter Receives: Other: Experimental: Dressing + adhesive + strips (parallel) |
| Dressing + adhesive + strips (perpend) | Experimental | Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed perpendicular to long axis of catheter Receives: Other: Experimental: Dressing + adhesive + strips (perpend) |
| Dressing + adhesive + strips + benzoin | Experimental | Transparent film dressing + topical skin adhesive + skin closure strips + topical benzoin (Compound Tincture of Benzoin USP 10%, Professional Disposables International, Inc., Orangeburg, NY, USA) spread in a 12 centimeter by 14 centimeter area around the insertion site Receives: Other: Experimental: Dressing + adhesive + strips + benzoin |
| Dressing + adhesive + strips + spray | Experimental | Transparent film dressing + topical skin adhesive + skin closure strips + medical adhesive spray (AdaptTM Medical Adhesive, Hollister Incorporated, Libertyville, IL, USA) in a 12 centimeter by 14 centimeter area around the insertion site Receives: Other: Experimental: Dressing + adhesive + strips + spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force required to dislodge catheter by 1 centimeter
This force will be measured using a dynamometer in Newtons
Measured: 1 study day
Secondary outcomes (1)
Force required to disrupt catheter dressing
This force will be measured using a dynamometer in Newtons
Measured: 1 study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start15 Feb 2018
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Regional Anesthesia MorbidityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Shaughnessy, MD, Principal investigator, Duke UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375190
- Sponsor's protocol ID
- Pro00081185
- Status last verified
- May 2018
- First submitted
- 5 Dec 2017
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kumar AH, MacLeod DB, Kumar KR, Ray N, Gadsden J. Comparison of perineural catheter fixation methods: a volunteer study. Anaesthesia. 2021 May;76(5):714-716. doi: 10.1111/anae.15372. Epub 2021 Jan 6. No abstract available.
PubMed 33406276
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Peripheral Nerve Catheter Securement Techniques at the Insertion Site in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03375190
- Acronym / sponsor ID
- Pro00081185
- Conditions
- Regional Anesthesia Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 15 Dec 2017 (actual)
- 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.
Continuous peripheral nerve block catheters are used for prolonged analgesia, but are often associated with complications such as catheter failure or dislodgement. This is a single center, prospective study to compare peripheral nerve catheter securement techniques at the insertion site in healthy volunteers.
Detailed description
This study will involve the placement of subcutaneous peripheral nerve catheters in healthy volunteers utilizing 6 different securement techniques. The primary outcome is the force required to dislodge the peripheral nerve catheter by 1 centimeter as measured by a dynamometer in Newtons. The secondary endpoint will be the force required to disrupt the catheter dressing.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dressing | Experimental | Other: DressingTransparent film dressing (TegadermTM CHG Chlorhexidine Gluconate IV Securement Dressing, 3M Health Care, St. Paul, MN, USA) alone |
| Dressing + adhesive | Experimental | Other: Dressing + adhesiveTransparent film dressing + topical skin adhesive (SwiftSetTM Topical Skin Adhesive, CovidienTM, Devon, UK) at insertion site |
| Dressing + adhesive + strips (parallel) | Experimental | Other: Experimental: Dressing + adhesive + strips (parallel)Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed parallel to long axis of catheter |
| Dressing + adhesive + strips (perpend) | Experimental | Other: Experimental: Dressing + adhesive + strips (perpend)Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed perpendicular to long axis of catheter |
| Dressing + adhesive + strips + benzoin | Experimental | Other: Experimental: Dressing + adhesive + strips + benzoinTransparent film dressing + topical skin adhesive + skin closure strips + topical benzoin (Compound Tincture of Benzoin USP 10%, Professional Disposables International, Inc., Orangeburg, NY, USA) spread in a 12 centimeter by 14 centimeter area around the insertion site |
| Dressing + adhesive + strips + spray | Experimental | Other: Experimental: Dressing + adhesive + strips + sprayTransparent film dressing + topical skin adhesive + skin closure strips + medical adhesive spray (AdaptTM Medical Adhesive, Hollister Incorporated, Libertyville, IL, USA) in a 12 centimeter by 14 centimeter area around the insertion site |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-85 years
- American Society of Anesthesiologists Physical Status I-II
- BMI 18-30 kg/m2
Key exclusion criteria (6 listed)
- Inability to cooperate with or understand protocol
- Inability to understand or speak English
- Allergy to adhesive or tape
- Local infection in lower extremities
- Neurologic deficit or disorder
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 |
|---|---|---|
| DressingTransparent film dressing (TegadermTM CHG Chlorhexidine Gluconate IV Securement Dressing, 3M Health Care, St. Paul, MN, USA) alone | Other | Dressing |
| Dressing + adhesiveTransparent film dressing + topical skin adhesive (SwiftSetTM Topical Skin Adhesive, CovidienTM Devon, UK) at insertion site | Other | Dressing + adhesive |
| Experimental: Dressing + adhesive + strips (parallel)Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed parallel to long axis of catheter | Other | Dressing + adhesive + strips (parallel) |
| Experimental: Dressing + adhesive + strips (perpend)Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed perpendicular to long axis of catheter | Other | Dressing + adhesive + strips (perpend) |
| Experimental: Dressing + adhesive + strips + benzoinTransparent film dressing + topical skin adhesive + skin closure strips + topical benzoin (Compound Tincture of Benzoin USP 10%, Professional Disposables International, Inc., Orangeburg, NY, USA) spread in a 12 centimeter by 14 centimeter area around the insertion site | Other | Dressing + adhesive + strips + benzoin |
| Experimental: Dressing + adhesive + strips + sprayTransparent film dressing + topical skin adhesive + skin closure strips + medical adhesive spray (AdaptTM Medical Adhesive, Hollister Incorporated, Libertyville, IL, USA) in a 12 centimeter by 14 centimeter area around the insertion site | Other | Dressing + adhesive + strips + spray |
Primary outcome
Force required to dislodge catheter by 1 centimeter
Time frame: 1 study day
This force will be measured using a dynamometer in Newtons
1 secondary outcome
Force required to disrupt catheter dressing
Time frame: 1 study day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Derived from this study: PubMed 33406276Kumar AH, MacLeod DB, Kumar KR, Ray N, Gadsden J. Comparison of perineural catheter fixation methods: a volunteer study. Anaesthesia. 2021 May;76(5):714-716. doi: 10.1111/anae.15372. Epub 2021 Jan 6. No abstract available.
- Individual participant dataSharing planned: No
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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.
Michael Shaughnessy, MD principal investigator
Duke UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dressing, Dressing + adhesive and Experimental: Dressing + adhesive + strips (parallel) in people with Regional Anesthesia Morbidity, run by Duke University 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 14 May 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Force required to dislodge catheter by 1 centimeter (time frame: 1 study day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03375190, which also lists 1 linked publication.
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 14 May 2018.