Simulation-Based Training for Ultrasound-Guided Perineural Catheter Insertion

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688271
• Other study ID #: 24882
• Status: Completed
• Phase: N/A
• First received: August 29, 2012
• Last updated: October 27, 2014
• Start date: August 2012
• Est. completion date: July 2014

Study information

• Verified date: October 2014
• Source: VA Palo Alto Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain Management
• Simulation
• Training
• Ultrasonography

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Palo Alto Health Care System	Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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. Review. — View Citation

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. — View Citation

Ilfeld BM, Enneking FK. Continuous peripheral nerve blocks at home: a review. Anesth Analg. 2005 Jun;100(6):1822-33. Review. — View Citation

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. Erratum in: Anesth Analg. 2006 Mar;102(3):875. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Marhofer P, Chan VW. Ultrasound-guided regional anesthesia: current concepts and future trends. Anesth Analg. 2007 May;104(5):1265-9, tables of contents. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline (time 0), interval assessment (time 1), and post-course (time 2)	No
Secondary	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.	Every 3 months post-training for 1 year	No