Are Arrow’s epidural/perineural catheters MRI safe?

The FlexTip Plus® and TheraCath® Epidural Catheters are made up of a combination of medical grade polyurethane and an inner stainless steel coil wire. Without conclusive study data, Arrow cannot recommend using the FlexTip Plus or TheraCath epidural catheter in an MRI. For a more detailed discussion on MRI safety, the following websites are listed for your convenience:

www.radiologyinfo.org/content/safety/mri_safety.htm
www.mrisafety.com

What is the indwell period for Epidural Catheters?

All Arrow Epidural Catheters are FDA cleared for use up to 72 hours.

What is the proper placement/removal process of an epidural catheter?

For instructions on proper epidural placement and removal procedures, read the instructions for use (IFUs). They are included with all of Arrow’s epidural products. Please read them before placing or removing our catheter.

Additional references:

Grass J.A., Haider N., Group M., et al. Incidence of complications related to epidural catheterization and maintenance for postoperative analgesia. Regional Anesthesia and Pain Management 23(3)108, 1998.

Jongleux E.F., Miller R., Freeman A. An entrapped epidural catheter in a postpartum patient. Regional Anesthesia and Pain Management 23(6) 615-617, 1998.

Pierre H.L., Block B.M., Wu C.L. Case report: difficult removal of a wire-reinforced epidural catheter. Journal of Clinical Anesthesia 15:140-141, 2003.

What clinical documentation exists to support the safety and efficacy for the FlexTip Plus® regarding the following topics?

Reduced Paresthesia

Banwell B.R., Morley-Foster P., Krause B.R. Decreased incidence of complications in parturients with the Arrow (FlexTip Plus™) epidural catheter. Canadian Journal of Anaesthesia, 45(4) 370-372, 1998.

Jaime F., Mandell L., Vallejo M.C. & Ramanathan S. Uniport soft-tip, open-ended catheters versus mulitport firm-tipped close-ended catheters for epidural labor analhesia: a quality assurance study. Journal of Clinical Anesthesia, 12:89-93, 2000.

Junega M., Kargas G.A., Miller D.L., et al. Comparison of epidural catheters induced parathesia in paturients. Regional Anesthesia, 20(Suppl.); 152, 1995.

Reduced vein cannulation

Banwell B.R., Morley-Foster P., Krause B.R. Decreased incidence of complications in parturients with the Arrow (FlexTip Plus™) epidural catheter. Canadian Journal of Anaesthesia, 45(4) 370-372, 1998.

Jaime F., Mandell L., Vallejo M.C. & Ramanathan S. Uniport soft-tip, open-ended catheters versus mulitport firm-tipped close-ended catheters for epidural labor analhesia: a quality assurance study. Journal of Clinical Anesthesia, 12:89-93, 2000.

Junega M., Kargas G.A., Miller D.L. Incidence of epidural vein cannulation in paturients with three different epidural catheters. Regional Anesthesia, 21(Suppl.); 4, 1996.

Reduced risk of epidural separation

Tsui C.H. B., Finucane B. Tensile strength of 19- and 20-gauge Arrow epidural catheters. Anesth Analg, 97:1524-1526, 2003.

Less one-sided blocks

Jaime F., Mandell L., Vallejo M.C. & Ramanathan S. Uniport soft-tip, open-ended catheters versus mulitport firm-tipped close-ended catheters for epidural labor analgesia: a quality assurance study. Journal of Clinical Anesthesia, 12:89-93, 2000.

Infection rates

Steffen P., Seeling W., Essig A., et al. Bacterial contamination of epidural catheters: microbiological examination of 502 epidural catheters used for postoperative analgesia. Journal of Clinical Anesthesia 16:92-97, 2004.

What educational programs are available to support the use of StimuCath®?

From time to time Arrow sponsors educational programs in regional anesthesia.

Contact your Arrow Medical Sales Specialist regarding off-campus workshops.

Is the StimuCath compatible with my particular stimulator?

The StimuCath was designed with a 2 mm female socket and is intended to work with nerve stimulators (approximately 90%) that have a 2 mm male pin. You may have a nerve stimulator that has an alternative connection; contact your Arrow Medical Sales Specialist for assistance.

Is the StimuCath compatible with my particular infusion pump?

Arrow’s SnapLock™ catheter adapter should be able to be used with all standard infusion pumps since the Luer-Lock connection of the SnapLock is designed to an industry standard. If for some reason it does not allow for connection, check with the infusion pump company regarding their luer-lock connection specifications.

What clinical documentation exists to support the safety and efficacy for StimuCath?

The following is a list of studies that support the safety and efficacy of the StimuCath:

Boezaart A.P., de Beer J.F., Nell M.L. Early experience with continuous cervical paravertebral block using a stimulating catheter. Regional Anesthesia and Pain Management, 28(5) 406-413, 2003.

Cohen N.P., Levine W.N., Marra G., et al. Indwelling interscalene catheter anesthesia in the surgical management of stiff shoulder: a report of 100 consecutive cases. Journal of Elbow and Shoulder Surgery, 9(4) 268-274, 2000.

Ilfeld B., Morey T., Wright T.H., et al. Interscalene perineural ropivacaine infusion: a comparison of two dosing regimens for post-operative analgesia. Regional Anesthesia and Pain Management, 29(1) 9-16, 2004

Wehling M.J., Koorn R. Leddell C., Boezaart A.P. Electrical nerve stimulation using a stimulating catheter: what is the lower limit? Regional Anesthesia and Pain Management, 29(3) 230-233, 2004

What are the hospital/post-op StimuCath care guidelines?

Arrow does not make specific recommendations concerning site care of peripheral nerve block catheters. There are no specific professional organizations or best practice guidelines that currently exist. Listed below are references that have been written that suggest different catheter management strategies.

Boezaart A. CPNBs at home: managing continuous peripheral nerve blocks. Arrow International 2004. This monograph can be obtained by contacting your Arrow Medical Sales Specialist.

Ilfeld, B.M., Kayser Enneking F. “Ambulatory Perineural Local Anesthetic Infusion.” Techniques in RA and Pain Mangagement, 7(1) Jan. 2003: 48-54.

What are the indications for using the StimuCath?

The StimuCath is indicated for use in operative or post-operative pain management strategies.

What types of blocks can the StimuCath be used for?

StimuCath can be used for any continuous sensory block that directly affects a specific peripheral nerve or plexus of nerves. Some common continuous nerve blocks include the following: interscalene, femoral, cervical paravertebral, infraclavicular, lumbar paravertebral and sciatic.

How do I place the StimuCath?

The StimuCath should be utilized by trained health care professionals well versed in peripheral nerve block procedures. Read all instructions for use (IFUs) included with the product. For demonstrations on proper placement and peripheral nerve block procedure technique, visit the Regional Anesthesia Study Center of Iowa at http://www.anesth.uiowa.edu/rasci/movies.html or contact your Arrow Medical Sales Specialist for a procedural CD.

How do I secure the StimuCath?

There are a few options available for securing the StimuCath Continuous Nerve Block Catheter. Arrow does suggest the use of the STATLOCK® stabilization device to secure the adapter comfortably to the patient and help prevent catheter displacement. The STATLOCK® stabilization device adhesive pad is custom designed for the Arrow SnapLock™ adapter that is part of the StimuCath device.

Other options include:

• Subcutaneous tunneling
• Transparent film dressings, (e.g. Tegaderm®)

STATLOCK® is a registered trademark of C. R. Bard , Inc. or an affiliate.
Tegaderm® is a registered trademark of 3M Company.

What are the infection rates for StimuCath?

Arrow is not aware of any documented cases of infection with use of the StimuCath. However, Arrow does recommend the use of aseptic technique and proper skin preparation which reduces the chance of bacterial colonization on the catheter. Documented sources indicate that bacterial colonization can occur with continuous peripheral nerve block catheters. However, these cases rarely lead to infection due to the short indwell time of the catheters. For more information, please reference the following document:

Philipe C., Ripart J., Lalourcey L., Veyrat E., L’Hermite J., et al. "The Continuous Femoral Nerve Block Catheter for Postoperative Analgesia: Bacterial Colonization, Infectious Rate and Adverse Effects". Anesthesia & Analgesia 93 (2001) 1045-9.