Background & Aims

Intrathecal opioid trialing is a recommended practice before pump implantation(1-6).  
The Polyanalgesic Consensus Conference (PACC -2017) concludes that no single study has shown that continuous IT trial is superior to other methods of IT trials in noncancer pain. There are equal levels of evidence for single shot trialing, bolus trialing, and continuous infusion.(1)
Most techniques described for trialing does not allow a flexible titration to balance analgesic efficacy and adverse reactions(1,2,3,8,9). On the other hand length of trial is important to avoid catheter related complications.

We describe the clinical utilization of an IT opioid trialing protocol using PCA IT bolus and a continuous infusion and patient self-evaluation chart_

Methods

We described in a previous poster (Abstract 3537. IASP 16th World Congress on Pain, Yokohama, Japan) an Intrathecal Opioid trialing Protocol using a portable PCA external pump combining Continuous Infusion + PCA rescue doses allowing an adequate titration and a continuous infusion that better resembles an implanted pump functionality. Patient self-evaluation chart allows patients to report side effects and pain ratings and modify daily dose. Finally, patient satisfaction is rated and chart is signed in front of a witness as an agreement to proceed with internal pump implantation.
In this poster we describe our 11 patient clinical experience with this trialing Protocol.

Results

All 11 patients were chronic non-malignant pain patients requiring high dose oral opioids with inadequate pain control. Eight patients were female and three males with an average age of 66.3 yr. (36 – 90 yrs.). Nine trials lasted three days, one trial was stopped at day two because the patient had urinary incontinence (previous gynecologic surgery) and one patient required an extra day because the need of additional baclofen boluses in trial day and day three for spasticity related pain. All trials had at least 24 hr. of a continuous infusion before ending.
All positive trials started with a pain rating VAS > 8 and final VAS < 3. Patient satisfaction was Very Satisfied in 7, Moderately Satisfied in 2, and Unsatisfied in 2. No serious side effects were observed. Most common were pruritus (7 ) and nausea (4 ). They resolved with dose adjustments by the end of the trial. 2 patients required urinary catheterization after the first bolus dose and recovered with dose reductions.

Conclusions

Prior to implantation of an internal IT pump, a successful trial is usually required. Consensus recommendation is that until RCT are developed each practitioner should use a trialing protocol based on safety, adherence to safe algorithmic principles, and proper patient monitoring. Described trial methodologies are IT single bolus, IT multiple bolus or IT continuous infusion. No combined methods using PCA boluses and continuous infusion were found in the literature.
This 3-day trialing technique provides an opportunity to assess IT opioid response with a safer and reliable methodology. Patient self-involvement and final agreement allows a more objective evaluation and helps decision making for internal pump implant.
Even our small sample size does not allow to draw any conclusions, it is remarkable that very low doses were required with minor and reversible side effects with good patient satisfaction.

References

1.Deer T.R., Hayek S., Pope J.E., et al. 2017. The Polyanalgesic Consensus Conference (PACC): Recommendations for Trialing of Intrathecal Drug Delivery Infusion Therapy. Neuromodulation 2017; E-pub ahead of print. DOI:10.1111/ner.12543
2.Bolash R, Mekhail N. Intrathecal pain pumps: indications, patient selection, techniques, and outcomes. Neurosurg Clin N Am. 2014 Oct;25(4):735-42
3.Prager J, Deer T et al. Best practices for intrathecal drug delivery for pain. Neuromodulation. 2014 Jun; 17(4):354-72.,
4.Raffaeli W, et al. Intraspinal therapy for the treatment of chronic pain: a review of the literature between 1990 and 2005 and suggested protocol for its rational and safe use. Neuromodulation. 2006 Oct;9(4):290-308
5.Pope, J, Deer, T et al. Clinical Uses of Intrathecal Therapy and Its Placement in the Pain Care Algorithm. Article first published online: 23 FEB 2016
6.Deer T, Chapple I, et al. Intrathecal drug delivery for treatment of chronic low back pain: report from the National Outcomes Registry for Low Back Pain. Pain Med. 2004 Mar; 5(1):6-13.
7.Bottros MM, Christo PJ. Current perspectives on intrathecal drug delivery. J Pain Res. 2014 Nov 6;7:615-26
8.Grider JS, Harned ME, Etscheidt MA. Patient selection and outcomes using a low-dose intrathecal opioid trialing method for chronic nonmalignant pain. Pain Physician. 2011 Jul-Aug; 14(4):343-51.
9.Ruan X, Couch JP. Unique low-dose intrathecal opioid trial, still in need of a feasibility check. Pain Physician. 2011 Sep-Oct;14(5):E462-3
10.Kuipers PW1, Kamphuis ET, van Venrooij GE, van Roy JP, Ionescu TI, Knape JT, Kalkman CJ. Intrathecal opioids and lower urinary tract function: a urodynamic evaluation. Anesthesiology. 2004 Jun;100(6):1497-503.

Presenting Author

Bashkansky, Diego

Poster Authors

Diego Bashkansky

MD

Fundación CENIT

Lead Author

Topics

  • Treatment/Management: Interventional Therapies – Intrathecal Drug Delivery