Background: Chronic pain is a significant health
challenge, and targeted drug delivery (TDD) is
increasingly utilized to manage patients who
have failed several treatment modalities. An
intrathecal trial is mandatory prior to permanent
implantation, with current guidelines recommending
inpatient observation of 23 hours or inpatient
admission for a continuous intrathecal infusion
opioid trial.
Objectives: TDD is an established method of the
delivery of opioids, and in this study, we aim to
provide a safe methodology using an outpatient
protocol.
Study Design: The study is designed as a retrospective
analysis on all non-malignant chronic
pain patients who were candidates for TDD, who
underwent an outpatient catheter trial from January
1, 2015 to December 31, 2016.
Setting: The study took place in an outpatientbased
community practice.
Methods: A retrospective chart review and
patient experience questionnaire were utilized
to assess the safety and efficacy of 98 patients
who underwent an intrathecal continuous infusion
catheter trial as an outpatient. The patients
underwent an intrathecal catheter placement at
the L2/3 interlaminar space with the catheter tip
at T10, regardless of pathology. The patients
were connected to an ambulatory pump and
were monitored as an outpatient for up to 3 days.
Results: Ninety of the 98 patients had greater
than 50% pain relief and proceeded to a permanent
intrathecal pump implant. The average
effective dose of morphine or hyrdromorphone
was 480 mcg/day. Using our outpatient and dosage
methodology, 0 patients had serious adverse
events which include infection, self-reported or
caregiver-reported respiratory difficulty, or an
emergency room (ER) visit during the trial.
The most common adverse events were postdural-
puncture headache (PDPH), which occurred
in 41% of the patients, nausea/vomiting in 28%
of the patients, and catheter dislodgment in 18%
of the patients.
Limitations: The sample size can be increased
to further prove safety. A multicenter study would
also prove to be a benefit.
Conclusion: Based on this study, we have devised
a safe and efficacious methodology for
performing an outpatient intrathecal trial using
a continuous infusion catheter, using low doses.
Implanted drug delivery systems are being increasingly
utilized for chronic non-malignant pain,
and this study implements a safe methodology.
This study hopes to provide better patient access
or an alternative to inpatient intrathecal infusion
trials, which can be cumbersome.
Key words: Targeted drug delivery, pump trial,
intrathecal opioid, intrathecal infusion, outpatient
trial, chronic non cancer pain
Patient Satisfaction Following Intrathecal Targeted Drug Delivery for Benign Chronic Pain: Results of a Single‐Center Survey Study
