Intrathecal Drug Delivery Pump Trial Procedure Note

Header

Date/Time: [Procedure date] [Start time - End time]

Location: [Facility name]; [inpatient / outpatient]

Proceduralist: [Name, credentials]

Trial Type: [single-shot intrathecal bolus / temporary intrathecal catheter with external pump / temporary epidural catheter with external pump / other: specify]

Imaging Guidance: [fluoroscopy / ultrasound / none]; Images saved: [Y / N]

Indication and Prior Therapy

Primary Indication: [pain / spasticity / mixed] — [Underlying diagnosis/etiology]

Rationale for Intrathecal Therapy Now: [Brief justification tying symptoms, goals, and current clinical context to intrathecal trial]

Prior Therapies: (Document modality, duration, outcome, and reason for discontinuation or inadequacy for each)

• Nonpharmacologic: [Modalities tried; outcome; reason inadequate]
• Non-opioid Medications: [Agents/classes; doses if available; outcome; adverse effects or contraindications]
• Opioid Therapy: [Approximate chronic MME/day; limiting factors/adverse effects/ineffectiveness] (Include formulation and route)
• Interventional Procedures/Surgeries: [Interventions/surgeries; dates if available; response durability; reason inadequate]

(If documentation from outside records is pending, explicitly state which elements are incomplete rather than inferring failure)

Predefined Trial Goals and Success Criteria

Pain Criterion: [Threshold, e.g., ≥50% reduction from baseline or ≥X-point decrease on specified scale] (Must be defined before results are recorded)

Functional Goal(s): [1–3 measurable, patient-meaningful functions to reassess post-trial, e.g., sleep duration, walking tolerance, specific ADLs]

Tolerability Criterion: [Acceptable side effect profile without serious neurologic or respiratory events] (Customize to agent: respiratory depression for opioids, neuropsychiatric effects for ziconotide, withdrawal risk for baclofen)

Observation Window: [0–8 hours for bolus / 24–72 hours for infusion / other: specify]

Baseline Assessment

Pain: [NRS / VAS / other]: [Score]; Locations: [Primary pain sites]; Analgesics last 24 hours: [Non-opioids and adjuvants]; [Opioids with total MME and rescue doses]

Function: [Standardized tool if used: PEG/ODI/other with score]; [2–3 functional anchors aligned to goals with measurable descriptors]

Focused Exam: [Neurologic exam pertinent to target symptoms and procedure level: motor, sensory, reflexes, gait if applicable] (For spasticity: include Modified Ashworth scale and functional assessment)

Safety: Vitals: [BP/HR/RR/SpO2/Temp]; Anticoagulant/Antiplatelet status: [Agent(s), last dose date/time, peri-procedural management]; Allergies: [Local anesthetics / contrast / trial drug / adhesive]; Infection Screen: [Skin at site; systemic symptoms]; NPO status: [Yes/No; last PO intake] (If sedation planned); Pregnancy status: [Confirmed negative / Not applicable] (If applicable)

Informed Consent and Safety Verification

Consent: Obtained for [intrathecal / epidural] [bolus / catheter with external pump] trial. Risks discussed: bleeding/hematoma, infection/meningitis, neurologic injury, post-dural puncture headache, drug-specific risks ([respiratory depression / neuropsychiatric effects / overdose and withdrawal risks]), catheter-related complications (if applicable), and possibility of inadequate relief. Alternatives discussed: [Alternatives considered]. Questions answered and patient (or legal representative) expressed understanding.

Universal Protocol: Time-out completed immediately before needle placement confirming correct patient, procedure, site/level, and equipment availability.

Sedation: [none / minimal / moderate / MAC]; Monitoring plan: [Cardiac, BP, SpO2, ETCO2 if applicable; frequency and personnel]

Procedure Details

Preparation: Patient position [prone / lateral / sitting]; skin prep [agent]; local anesthetic [agent, concentration, volume]; antibiotic prophylaxis [given / not indicated]; target interspace [level].

Technique: [Approach and level] accessed using [needle type and gauge]. [Confirmation of correct space: CSF return for intrathecal / loss of resistance for epidural]. (If fluoroscopy used, document contrast confirmation and spread pattern.) For catheter trials: Catheter insertion depth: [cm]; Tip level: [vertebral level]; Securing method: [suture / adhesive / securement device]; External pump: [model]; Initial settings: [basal rate; bolus parameters; reservoir concentration]. Fluoroscopy: [time and dose if tracked].

Trial Medication(s): (Document each agent on separate line)

• Agent: [Generic name] — Concentration: [mg/mL or mcg/mL]; Dose: [mg or mcg]; Volume: [mL]; Route: [intrathecal / epidural]; Mode: [bolus / infusion]; Preservative-free: [confirmed]. For infusions: Start time: [time]; Rate(s): [mL/hr or mcg/hr]; Titrations: [steps and times]. For admixtures: [Components and final concentrations].

Systemic Analgesic Management: Baseline opioid regimen: [medications with daily MME]. During trial: [continued / reduced / held / converted] with details. Rescue medications during trial: [Allowed agents, dosing rules, and how rescue use will factor into success interpretation].

Complications: Estimated blood loss: [minimal / mL]. Complications: [none / wet tap / paresthesia / hypotension / bleeding / difficult placement / catheter malfunction / other: specify]. Immediate procedural outcome: [tolerated well / aborted: reason].

Monitoring and Response

Monitoring: Recovery location: [PACU / clinic / ward]; duration: [hours]. Vitals and neurologic checks: [frequency]. Sedation/respiratory monitoring: [SpO2/ETCO2/Level of consciousness; continuous vs intermittent] (If opioids or sedation used).

Pain Scores Over Time: (Use same scale as baseline; compute percent improvement from documented scores only)

Timepoint	Pain Scale	Score	Rescue Analgesic Use	Comments
Baseline (pre-dose)	[NRS / VAS / other]	[Score]	[Agent/dose or none]	[Notes]
[30–60 min post-dose / AM Day 1]	[Scale]	[Score]	[Agent/dose or none]	[Notes]
[Peak effect window]	[Scale]	[Score]	[Agent/dose or none]	[Notes]
[End-of-effect / PM Day 1]	[Scale]	[Score]	[Agent/dose or none]	[Notes]
[Additional timepoints as needed]	[Scale]	[Score]	[Agent/dose or none]	[Notes]

Best achieved pain score: [Score]. Percent improvement from baseline: [%] (Calculate from documented scores only)

Side Effects: (Document presence/absence, severity, and interventions)

Timepoint	Adverse Effect	Severity	Intervention	Outcome
[Timepoint]	[pruritus / nausea-vomiting / dizziness / urinary retention / hypotension / cognitive or mood change / oversedation / respiratory depression / headache / new neurologic deficit / other]	[mild / moderate / severe]	[Treatment or none]	[resolved / persistent]
[Additional timepoints]	[Adverse effect]	[Severity]	[Intervention]	[Outcome]

Functional Response: [Reassessment of baseline functional anchors with measured results]; [Repeat standardized tool score if used]. Clinician judgment: [Improvement attributable to analgesia vs sedation/weakness].

Analgesic Consumption: [Rescue medication usage during trial compared to baseline]

Patient Global Impression: [Patient-reported summary of trial experience]

(If trial still in progress: "In progress - addendum required. Final assessment scheduled for [date/time].")

Trial Outcome and Recommendation

Preset Criteria (restated): Pain: [threshold]; Function: [goals]; Tolerability: [criteria]; Observation window: [timeframe].

Outcome vs Criteria:

• Pain criterion: [met / not met / partially met] — [Justification with documented scores and percent change]
• Functional goal(s): [met / not met / partially met] — [Justification]
• Tolerability: [acceptable / unacceptable] — [Adverse effects summary and clinical significance]

Final Recommendation: [proceed to permanent implant / do not proceed / repeat or modify trial: specify modification]. Alternate plan if not proceeding: [Next steps].

Flags requiring deferral or further evaluation: [none / new neurologic deficit / infection concern / significant cognitive or psychiatric effects / clinically significant respiratory depression / other]

Disposition and Follow-up

Disposition: [home / observation / admit]. Discharge criteria met: [Y / N: brief note if no].

Instructions: Activity restrictions: [restrictions]; wound/catheter care: [instructions if applicable]; warning signs requiring urgent evaluation: [fever, severe headache, new weakness or numbness, urinary retention, respiratory difficulty, signs of infection].

Follow-up Plan: [Trial check-in timing and responsible clinician]; [Trial end date and catheter removal plan for infusion trials]; [Appointment to discuss permanent implant candidacy].

Signature

[Performing clinician name, credentials] — [Date/Time]

(Documentation guidance: Do not infer information not explicitly obtained. Never infer quantified improvement—calculate only from documented scores. If information is unavailable, document why rather than leaving blank.)