Neuraxial Access Devices

Purpose and Scope

This guideline provides evidence-based recommendations for the safe and effective management of neuraxial access devices, including epidural and intrathecal catheters, implanted neuraxial ports, and intrathecal drug delivery (ITDD) systems. It is intended for use by clinicians across acute care, outpatient, and home care settings who participate in the insertion, management, medication administration, and complication prevention associated with these specialized infusion systems.

1. Foundational Principles

1.1 System Identification and Differentiation

Neuraxial access devices and their associated administration sets must be clearly identified and labeled as specialized infusion systems. They must be visually and physically differentiated from all other infusion routes, including intravenous, enteral, and peripheral access systems. This differentiation is essential to prevent potentially fatal misconnection errors.

The use of neuraxial-specific (NRFit) connectors, approved by the International Organization for Standardization (ISO), is the standard for preventing inadvertent administration of non-neuraxial medications, solutions, or enteral feedings into the neuraxial space. Standard luer needleless connectors and infusion administration sets are incompatible with NRFit connectors by design, providing a critical safety barrier.¹⁻³

1.2 Medication Requirements

All medications administered via a neuraxial route must be preservative-free. The presence of preservatives in neuraxial medications can cause neurotoxicity and permanent neurological damage. Additionally, all infusion solutions administered via the neuraxial route require filtration using a 0.2-micron filter that is surfactant-free, particulate-retentive, and air-eliminating.²,³

1.3 Authorization and Oversight

Neuraxial access device placement, removal, care, management, and medication administration must be performed either by or upon the order of an authorized provider. These activities are governed by regulations established by regulatory and accrediting bodies, as well as organizational policies and procedures. Clinicians must be competent in the anatomy and physiology relevant to neuraxial access, infusion administration techniques, and complication management strategies.

2. Clinical Indications

2.1 Acute Pain Management

Neuraxial infusions are indicated for the management of short-term acute pain in hospitalized patients. Common applications include post-surgical analgesia, trauma-related pain, and labor analgesia. In these cases, a temporary epidural catheter is typically placed for analgesic or anesthetic medication administration. Patient-controlled epidural analgesia (PCEA) may be employed to allow patient-directed bolus dosing within physician-prescribed parameters.¹⁻³

2.2 Chronic Pain Management

For patients with chronic cancer-related or non-malignant pain that is refractory to conventional medical management, or when systemic analgesics produce intolerable side effects, neuraxial drug delivery offers an alternative approach. Intrathecal infusions may include opioids alone, opioids combined with ziconotide (considered a first-line adjuvant), local anesthetics, or opioids combined with local anesthetics and clonidine.³⁻¹²

Access options for chronic pain management include long-term tunneled catheters, implanted ports with epidural or intrathecal catheters, and implanted intrathecal drug delivery (ITDD) systems. ITDD systems consist of an intrathecal catheter connected to a surgically implanted programmable infusion pump.

Patient selection criteria for ITDD therapy include demonstrated adherence to treatment plans, ability to maintain ongoing appointments for pump maintenance, general medical and psychosocial status, adequacy of social support, and disease prognosis.¹³,¹⁴

2.3 Medication Trialing and Dosing

The clinical site for trialing intrathecal medications in patients with chronic pain generally requires hospital admission. This setting provides flexibility for trialing different intrathecal medications and regimens while ensuring appropriate monitoring.

Low-dose opioid trialing may be considered in the outpatient setting with a shorter observation period; however, overnight hospital admission is recommended when initiating therapy with higher starting doses. Trialing methods may include a single bolus injection or catheter-based bolus and infusion administration via either the epidural or intrathecal route.³,¹²,¹⁴,¹⁵

Careful medication titration is required during initiation and when converting between routes (such as from intravenous to epidural to intrathecal), switching between medications, or adding adjuvant agents. Established opioid conversion guidelines should be utilized, with doses starting conservatively. As a general principle, intrathecal opioid dosing is approximately one-tenth of the equivalent epidural dose.

Research has demonstrated that ITDD therapy provides similar efficacy with no significant difference in side effects when comparing patients under 65 years of age to those 65 years and older. In appropriately selected patients, intrathecal opioids can help avoid the unwanted side effects associated with oral pain management.¹⁶

2.4 Spasticity Management

Intrathecal baclofen infusion is an established treatment for spasticity refractory to oral management. ITDD systems allow for precise medication delivery at constant or variable rates, with reservoir refilling scheduled according to individual patient requirements, typically every one to six months.⁷⁻⁹,¹⁷,¹⁸

2.5 Central Nervous System Malignancy

Intrathecal drug delivery is utilized for the treatment of primary central nervous system cancers and leptomeningeal metastases, allowing direct medication delivery to the cerebrospinal fluid compartment.³,¹⁹,²⁰

3. Pre-Procedure Assessment

3.1 Coagulation Status Evaluation

A thorough assessment of the patient’s coagulation status is mandatory before epidural or intrathecal catheter insertion or removal. Anticoagulants must be withheld for appropriate periods to minimize the risk of spinal hematoma, which can result in permanent paralysis.¹,²,¹⁴,²¹⁻²³

The pre-procedure evaluation should include documentation of the dosage, route, date, and time of the last anticoagulant administration, along with review of current coagulation panel results. Clinicians should consult guidance from the American Society of Regional Anesthesia and Pain Medicine and the Polyanalgesic Consensus Conference guidelines for specific time frames to withhold each class of anticoagulant.

Regarding platelet count, spinal epidural hematoma in thrombocytopenic patients with platelet counts of 75,000/microliter or above is rare. While no consensus exists regarding the minimum threshold platelet count, patients should be monitored carefully for any signs of bleeding, such as petechiae or bruising, during the first 24 hours following the procedure.

4. Medication Safety Practices

4.1 Preventing Medication Errors

Errors resulting from inadvertent administration of intravenous medications via the intrathecal route, or neuraxial medications administered intravenously, have caused profound toxicity and death. Documented cases include inadvertent intrathecal administration of vinca alkaloids, potassium chloride, and antibiotics, as well as inadvertent intravenous administration of epidural anesthetic solutions containing fentanyl and bupivacaine or ropivacaine.¹⁹,²⁰,²⁴⁻²⁸

The following practices are essential for preventing such errors.

NRFit Connector Implementation: Neuraxial medications should be prepared in NRFit syringes and administered via NRFit administration sets. All clinicians involved in neuraxial procedures must be educated about NRFit connectors and the rationale for their use. Organizational procedures, order sets, and pharmacy preparation and dispensing processes should be updated to incorporate NRFit connectors.

Line Tracing Protocol: All catheters, administration sets, and add-on devices must be traced from the patient connection site to the solution container before connecting or reconnecting any infusion or device. This tracing should occur at each care transition to a new setting or service and as part of the handoff process.

Antineoplastic Medication Administration: Intrathecal antineoplastic medications are administered by physicians and advanced practice providers in accordance with local and national regulations and organizational policy. Intravenous vinca alkaloid administration should be prepared in a small-volume infusion bag (minibag) and administered as an infusion rather than via syringe. This practice is also advised for other antineoplastics such as anthracyclines.

Medication Preparation and Storage: Intrathecal medications should be prepared and stored separately from other parenteral medications and clearly labeled “For Intrathecal Use.” Access to epidural analgesia should be limited, with the clinician who will administer the medication bringing it to the patient’s bedside immediately before use.

Independent Double-Check: An independent double-check with another qualified nurse, pharmacist, or physician must be performed prior to neuraxial medication administration. This verification is also required when changing the syringe or medication container, rate, or concentration. The double-check should include verification that the intraventricular or intrathecal route is safe for the medication and its compatibility with preservative-free 0.9% sodium chloride or Elliotts B solution (used for methotrexate sodium and cytarabine).

Time-Out Procedure: A time-out procedure should be performed immediately prior to neuraxial medication administration.

5. Aseptic Technique and Infection Prevention

5.1 Procedural Requirements

Surgical-level Aseptic Non Touch Technique (ANTT®) must be maintained during catheter insertion, implanted neuraxial port access, and access and filling of implantable intrathecal drug delivery systems.¹⁻³,²⁹

Clinicians should wear a mask during all neuraxial medication injections to reduce the risk of droplet transmission of oropharyngeal flora to the injection site or sterile field.

5.2 Skin Antisepsis

Alcohol should be avoided during device access and site care for neuraxial devices. Appropriate alternatives include aqueous chlorhexidine solution or povidone-iodine solution. Regardless of the antiseptic agent selected, it must be allowed to fully dry before proceeding, as all antiseptic agents have the potential for neurotoxicity if introduced into the neuraxial space.²,³

6. Catheter Verification and Infusion Administration

6.1 Position Confirmation

The position of external epidural and intrathecal access devices must be confirmed before any infusion or medication administration.²,³

For epidural access devices, aspiration should be performed prior to medication administration to verify the absence of spinal fluid and blood. If greater than 0.5 mL of clear, serous fluid is aspirated, the provider must be notified and medication administration should be withheld. This finding is indicative of catheter migration into the intrathecal space.

For intrathecal and ventricular access devices, aspiration prior to medication administration should confirm the presence of cerebrospinal fluid and the absence of blood.

6.2 Infusion Pump Requirements

An electronic infusion pump with anti-free-flow protection must be used to administer continuous neuraxial infusions. The administration set used with external epidural or intrathecal infusions should not contain any injection ports, reducing the risk of inadvertent access.²,³

For ITDD systems, the implanted pump provides precise medication dosage at constant or variable rates. Reservoir refilling is scheduled based on individual patient requirements, typically ranging from every one to six months.²,³,¹³

7. Intrathecal Drug Delivery System Management

7.1 Competency Requirements

Clinicians who perform ITDD system access procedures, medication filling, and pump programming must be specifically educated and demonstrate competency in these procedures. Required skills include pump interrogation and programming, pump refill with strict aseptic technique, recognition of a “pocket fill” (accidental injection into the subcutaneous tissue surrounding the pump rather than into the pump reservoir), identification of residual volume discrepancies, and appropriate response actions.

Reports indicate that inadequate training contributes to adverse events. Analysis of malpractice claims has identified pump refill errors and nerve damage from intraoperative injury, infection, or intrathecal granuloma formation as causes of patient injury. Inadvertent pocket fills and programming errors were frequently performed by clinicians lacking adequate education and training.⁷,¹³,¹⁴,³¹⁻³⁴

Consensus guidelines recommend a minimum of 20 supervised pump refills for competency assessment before clinicians perform refills independently.

7.2 Refill Procedures and Monitoring

Patients should be observed for 30 to 60 minutes following a pump refill. If a pocket fill is suspected, the most appropriate confirmation method is to re-access the pump reservoir and check for a volume discrepancy.³¹,³³

Ultrasound guidance may be considered for pump refills when the port is difficult to locate or palpate, and ultrasound can help identify pocket fills. However, ultrasound is less effective than palpation for identifying the septum in ITDD systems with a raised septum design.⁶,³⁶,³⁷

Signs and symptoms of a pocket fill include swelling at the pump site, patient report of burning or stinging during the procedure, and technical difficulty encountered during the fill. In the event of a suspected pocket fill, the patient should be monitored in a controlled setting and transferred to the emergency department for evaluation.³³

A pilot program demonstrated that pump refills performed by a nurse and physician team in a hospital-at-home setting were effective, safe, and associated with high patient satisfaction. The program included a post-refill ultrasound to verify the absence of subcutaneous drug injection.³⁵

7.3 Pain Management During Procedures

ITDD system access is a needle-related procedure, and appropriate pain management should be provided.³⁰

7.4 Troubleshooting Therapy Failure

When a patient demonstrates inadequate response to therapy despite adjustments in pump rate, evaluation for potential catheter dysfunction is warranted.⁷,¹³

7.5 Emergency Department and Hospital Evaluation

Patients with ITDD systems who present to the emergency department or are admitted to the hospital require specialized evaluation. Essential information to obtain includes the level of the catheter tip, medications and concentrations being infused (continuous and patient-administered doses if applicable), pump reservoir volume, dates of last refill and refill alarm, and assessment for signs and symptoms of medication underdose or overdose.¹³,¹⁸

8. Dressing and Site Management

8.1 Dressing Application and Maintenance

A sterile dressing that is clean, dry, and intact should be applied and maintained over the catheter insertion site. A transparent semipermeable membrane (TSM) dressing is recommended to allow continuous site visualization.²⁻⁴,³⁸,³⁹

Chlorhexidine-impregnated dressings should be considered for patients with epidural access devices. Research has demonstrated significant reductions in epidural skin colonization and catheter tip colonization with their use.³,⁴⁰

8.2 Catheter Securement

A securement product or tape should be used to create a tension loop of tubing secured to the patient’s body. This reduces the risk of accidental catheter dislodgement, which is a recognized complication of external epidural catheters. Currently, limited data exist regarding the optimal securement technique.

8.3 Site Care for Tunneled and Implanted Devices

Site care and dressing changes over tunneled and accessed implanted neuraxial devices should be performed according to organizational policy. Evidence-based recommendations for the frequency of routine site care and dressing changes are not currently established.

9. Patient Monitoring

9.1 Monitoring Frequency

Patients require frequent assessment for 24 hours after initiating or restarting a neuraxial infusion. Recommended monitoring intervals are every one to two hours until stable, then every four hours thereafter.¹,²,¹³,⁴¹,⁴²

9.2 Assessment Parameters

Comprehensive patient monitoring should include the following parameters.

Pain Assessment: Pain ratings using a validated pain scale appropriate to the patient’s age and condition should be obtained both at rest and with activity.

Vital Signs: Blood pressure, pulse, respiratory rate, and temperature should be documented at each assessment.

Sedation Level: If opioids are being administered via the neuraxial route, level of sedation should be assessed.

Patient-Controlled Doses: For patients using patient-controlled epidural analgesia, the number of bolus doses delivered should be tracked.

Obstetric Patients: For patients in labor, fetal status and response to the epidural infusion require monitoring.

Side Effects and Adverse Events: Assessment for side effects such as pruritus, nausea, urinary retention, orthostatic hypotension, motor block, and tinnitus (ringing in the ears) should be performed.

Neurological Changes: Changes in sensory or motor function require immediate attention. These include new onset of pain, unexplained back pain, leg pain, bowel or bladder dysfunction, and motor block.

Site Assessment: The catheter exit site should be inspected for signs and symptoms of infection, including erythema, swelling, or localized pain. Catheters should be removed when such signs are present. Additional signs and symptoms of infection may include back pain, tenderness, drainage, fever, malaise, neck stiffness, progressive numbness, or motor block.

Catheter Migration: Signs of catheter tip migration include a change in external catheter length, decreased pain control, or increased side effects.

Dressing Integrity: The dressing should be assessed for intactness and absence of moisture or leakage.

System Connections: Catheter and administration set connections should be verified as secure.

Infusion Pump Parameters: The electronic infusion pump should be reviewed for history of analgesic use and correct administration parameters.

ITDD Pump Complications: For patients with implanted pumps, complications may manifest as loss of pain control, oversedation (with opioid infusions), or changes in spasticity (increased or decreased, with baclofen infusions).

Respiratory Monitoring: Oxygen saturation via pulse oximetry and end-tidal carbon dioxide (capnography) should be monitored according to organizational policy. Capnography is more sensitive than pulse oximetry alone for identifying respiratory depression.

10. Patient and Caregiver Education

10.1 Essential Education Topics

Patient education should address the following areas²,³,¹³,³³:

Procedure Understanding: Patients should understand the principles of neuraxial access device placement and what to expect during the insertion procedure.

Medication Disclosure: The importance of reporting alcohol use and all medications, including prescription, over-the-counter, and complementary therapies, should be emphasized.

Warning Signs: Patients must be instructed to report changes in pain perception, new or worsening side effects, and fever, and to seek immediate medical care when such symptoms occur.

Overdose Recognition: Clinical signs of overdose include dizziness, sedation, euphoria, anxiety, seizures, and respiratory depression.

Underdose Recognition: Signs of medication underdose include increased pain or, in the case of intrathecal baclofen, increased spasticity.

Activity Restrictions for ITDD Patients: Patients with newly implanted ITDD systems should avoid bending or twisting at the waist for six weeks following implantation. Ongoing caution regarding active, repetitive bending or twisting of the spine is advised, as these movements may increase the risk of catheter damage or dislodgement. Increased pain and withdrawal symptoms may indicate catheter-related complications.

Appendix A: Quick Reference Tables

Table 1: Aspiration Guidelines by Access Type

Table 2: Signs of Overdose vs. Underdose

Table 3: Monitoring Schedule After Neuraxial Infusion Initiation

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