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Pain ManagementNCT01688271

Simulation-Based Training for Ultrasound-Guided Perineural Catheter Insertion

An observational study of Pain Management and Simulation, run by VA Palo Alto Health Care System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will determine the efficacy of a teaching program incorporating hybrid simulation in training practicing anesthesiologists on ultrasound (US)-guided continuous peripheral nerve block (CPNB). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pain Management, Simulation, Training
How many people
32 participants
Where
1 siteUnited States
Study dates
Aug 2012to Jul 2014
Phase
Observational
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Active board certificated (American Board of Anesthesiologists) Anesthesiologists in practice ten years or more.

Who may be able to join

  • Anesthesiologists in practice ten years or more; active board certification (American Board of Anesthesiologists); active license to practice medicine in California; and willingness to spend one full day (8 hours) participating in the standardized workshop and undergo interval survey and interview follow-up for one year.

Who cannot join

  • Formal training (e.g., post-graduate fellowship) in regional anesthesia; current practice includes the routine performance of US-guided PNB (≥10 blocks per month); or visual, hearing, or other communication impairment that would interfere with video recording or require substantial deviation from the standardized teaching curriculum.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

Other trials in United States

About this study

Official title: A Prospective Study to Determine the Efficacy of Simulation-based Training on Practicing Anesthesiologists' Acquisition of Ultrasound-guided Perineural Catheter Insertion Skills

This study will determine the efficacy of a teaching program incorporating hybrid simulation in training practicing anesthesiologists on ultrasound (US)-guided continuous peripheral nerve block (CPNB).

This study will also examine the extent of practice change following participation in a regional anesthesia teaching program incorporating hybrid simulation. In addition, this study will assess remaining obstacles to incorporating the use of US-guided perineural catheters through identifying potential future interventions and "tool-kits" for setting up perineural catheter programs.

Read the detailed description

Study subjects will complete a pre-course survey to assess prior experience then participate in a standardized one-day workshop comprised of two sessions; 1) a didactic lecture and model scanning session and 2) a simulation session. Quantitative and qualitative assessments will be performed using video analysis by two blinded reviewers after equipment orientation (baseline), following first session, and following second session. Performance times, number of attempts, and composite scores for procedural performance and ergonomics will be analyzed within and between groups. Every 3 months for one year, subjects will be surveyed to assess implementation of PNB in practice and identify remaining barriers.

Keywords
simulation, ultrasound, perineural infusion, continuous peripheral nerve block
Medical subject headings
Agnosia

What participants receive

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

Study groups in NCT01688271
Study groupRoleWhat they receive
AnesthesiologistsNot described

What is being measured

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

  1. Change in video assessment score from baseline

    The primary outcome is the change in composite score from baseline assessment based on the video analysis tool used by blinded reviewers. The baseline assessment at time 0 will take place after initial orientation to the simulation lab. This procedure will take approximately 15 min to perform and record. After the morning session of training (4 hours), the interval assessment at time 1 will take place in the same manner. The final assessment will take place following the entire course (8 hours total) according to the same procedures at time 2. Video recordings will be reviewed at a later date after completion of the training day.

    Measured: baseline (time 0), interval assessment (time 1), and post-course (time 2)

Secondary outcomes (1)

  1. Implementation of new training

    Starting 3 months after the workshop and every 3 months thereafter for one year, subjects will be sent an online practice assessment survey similar to the pre-course survey by the research assistant and will be asked to report their case logs.

    Measured: Every 3 months post-training for 1 year

Timeline

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

  1. First posted19 Sep 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01688271
Sponsor's protocol ID
24882
Status last verified
Oct 2014
First submitted
29 Aug 2012
Last updated
29 Oct 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Sites BD, Spence BC, Gallagher JD, Wiley CW, Bertrand ML, Blike GT. Characterizing novice behavior associated with learning ultrasound-guided peripheral regional anesthesia. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):107-15. doi: 10.1016/j.rapm.2006.11.006.

    PubMed 17350520

  • Ajmal M, Power S, Smith T, Shorten GD. Ergonomic task analysis of ultrasound-guided femoral nerve block: a pilot study. J Clin Anesth. 2011 Feb;23(1):35-41. doi: 10.1016/j.jclinane.2010.06.006.

    PubMed 21296245

  • Ilfeld BM, Enneking FK. Continuous peripheral nerve blocks at home: a review. Anesth Analg. 2005 Jun;100(6):1822-1833. doi: 10.1213/01.ANE.0000151719.26785.86.

    PubMed 15920221

  • Ilfeld BM, Gearen PF, Enneking FK, Berry LF, Spadoni EH, George SZ, Vandenborne K. Total knee arthroplasty as an overnight-stay procedure using continuous femoral nerve blocks at home: a prospective feasibility study. Anesth Analg. 2006 Jan;102(1):87-90. doi: 10.1213/01.ane.0000189562.86969.9f.

    PubMed 16368810

  • Ilfeld BM, Mariano ER, Williams BA, Woodard JN, Macario A. Hospitalization costs of total knee arthroplasty with a continuous femoral nerve block provided only in the hospital versus on an ambulatory basis: a retrospective, case-control, cost-minimization analysis. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):46-54. doi: 10.1016/j.rapm.2006.10.010.

    PubMed 17196492

  • Sites BD, Chan VW, Neal JM, Weller R, Grau T, Koscielniak-Nielsen ZJ, Ivani G; American Society of Regional Anesthesia and Pain Medicine; European Society Of Regional Anaesthesia and Pain Therapy Joint Committee. The American Society of Regional Anesthesia and Pain Medicine and the European Society Of Regional Anaesthesia and Pain Therapy Joint Committee recommendations for education and training in ultrasound-guided regional anesthesia. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):40-6. doi: 10.1097/AAP.0b013e3181926779.

    PubMed 19258987

  • Hadzic A, Vloka JD, Kuroda MM, Koorn R, Birnbach DJ. The practice of peripheral nerve blocks in the United States: a national survey [p2e comments]. Reg Anesth Pain Med. 1998 May-Jun;23(3):241-6.

    PubMed 9613533

  • Kopacz DJ, Neal JM. Regional anesthesia and pain medicine: residency training--the year 2000. Reg Anesth Pain Med. 2002 Jan-Feb;27(1):9-14. doi: 10.1053/rapm.2002.29715.

    PubMed 11799499

  • Kopacz DJ, Neal JM, Pollock JE. The regional anesthesia "learning curve". What is the minimum number of epidural and spinal blocks to reach consistency? Reg Anesth. 1996 May-Jun;21(3):182-90.

    PubMed 8744658

  • Marhofer P, Chan VW. Ultrasound-guided regional anesthesia: current concepts and future trends. Anesth Analg. 2007 May;104(5):1265-9, tables of contents. doi: 10.1213/01.ane.0000260614.32794.7b.

    PubMed 17456684

  • Mariano ER, Cheng GS, Choy LP, Loland VJ, Bellars RH, Sandhu NS, Bishop ML, Lee DK, Maldonado RC, Ilfeld BM. Electrical stimulation versus ultrasound guidance for popliteal-sciatic perineural catheter insertion: a randomized controlled trial. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):480-5. doi: 10.1097/AAP.0b013e3181ada57a.

    PubMed 19920423

  • Mariano ER, Loland VJ, Sandhu NS, Bellars RH, Bishop ML, Afra R, Ball ST, Meyer RS, Maldonado RC, Ilfeld BM. Ultrasound guidance versus electrical stimulation for femoral perineural catheter insertion. J Ultrasound Med. 2009 Nov;28(11):1453-60. doi: 10.7863/jum.2009.28.11.1453.

    PubMed 19854959

  • Neal JM, Hsiung RL, Mulroy MF, Halpern BB, Dragnich AD, Slee AE. ASRA checklist improves trainee performance during a simulated episode of local anesthetic systemic toxicity. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):8-15. doi: 10.1097/AAP.0b013e31823d825a.

    PubMed 22157743

  • Boulet JR, Murray DJ. Simulation-based assessment in anesthesiology: requirements for practical implementation. Anesthesiology. 2010 Apr;112(4):1041-52. doi: 10.1097/ALN.0b013e3181cea265.

    PubMed 20234313

Questions about this trial

What is this clinical trial studying?

An observational study of Pain Management and Simulation, run by VA Palo Alto Health Care System 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 1 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: finished, as of the sponsor's last update on 29 Oct 2014. 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?

Change in video assessment score from baseline (time frame: baseline (time 0), interval assessment (time 1), and post-course (time 2)). 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 NCT01688271, which also lists 14 linked publications.

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 29 Oct 2014.

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