A Comparison of Refill Procedures and Patient Outcomes Following Ultrasound-Guided and Template-Guided Intrathecal Drug Delivery Systems With Recessed Ports

Singa, Ramesh M.; Buvanendran, Asokumar; McCarthy, Robert J.

doi:10.1111/ner.13086

Cited by 4 publications

(7 citation statements)

References 18 publications

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“…For one, the pain study did not describe the patient population (ie, BMI or functional mobility) but it is likely that the pain population was better able to position themselves and may have had lower BMIs, which would make the template less challenging to use. This hypothetical difference between the groups is supported by the discrepancy in the template refill times between our study (116–1371 seconds) and the pain study (35–109 seconds) 17 . Finally, the pain study time included the setup of the ultrasound, including sterile technique for real‐time needle visualization, 17 which was not done in our study.…”

Section: Discussionmentioning

confidence: 71%

“…In a larger clinical trial that compared ultrasound to template-guided intrathecal pain pumps, the participants preferred the ultrasound-guided method over that of the template and had lower NRS pain scores with the ultrasound-guided procedure. 17 Given these findings, we hypothesize that a fully powered study would be able to detect more differences than our pilot study. Interestingly, the larger study found that the ultrasound-guided procedure took longer, 17 in contrast to the findings of this study.…”

Section: Discussionmentioning

confidence: 80%

“…Although the average pain scores and provider‐reported difficulty improved with decreased patient satisfaction, these differences were <1 (except for pain during procedure of 1.2) and it is unclear from the pilot data if it would be clinically meaningful to a patient. In a larger clinical trial that compared ultrasound to template‐guided intrathecal pain pumps, the participants preferred the ultrasound‐guided method over that of the template and had lower NRS pain scores with the ultrasound‐guided procedure 17 . Given these findings, we hypothesize that a fully powered study would be able to detect more differences than our pilot study.…”

Section: Discussionmentioning

confidence: 81%

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Ultrasound guidance versus landmark guidance for intrathecal baclofen pump refill: A randomized pilot study

Stone

Wei

Reger

2023

PM&R

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BackgroundRefilling difficult‐to‐access intrathecal baclofen (ITB) pumps by a trainee can result in longer procedures, more needle punctures, and more frequent attending interventions. Though ultrasound guidance can be used, there has not been an investigation into the impact of ultrasound guidance on refill outcomes.ObjectiveTo determine the feasibility of ultrasound guidance during difficult ITB refills to improve the experience of patients and providers.DesignNonblinded, randomized controlled trial with crossover element.SettingOutpatient clinic at a tertiary academic rehabilitation hospital.ParticipantsPatients ≥18 years old with historically difficult refills who were scheduled for repeat refills. “Difficult” was defined as body mass index > 30.0, a deep/tilted pump, previously requiring >1 skin puncture, or previously needing special positioning to access.InterventionsConsented participants were randomized into a template‐guided group (control) or an ultrasound‐guided group (experimental) using a coin flip. Patients were crossed over if (1) a second refill occurred during the study period or (2) the randomized technique failed.Main Outcome MeasuresThe primary measure was time spent with needle under skin (seconds). Number of needle punctures and needle passes, frequency of attending intervention, pain during and after the procedure, patient satisfaction, and practitioner perceived difficulty were investigated.ResultsSeventeen patients underwent 21 refills (12 template guided and 9 ultrasound guided). No patients experienced adverse events. Although without statistically significant difference, the average time in the experimental group was shorter than the control (175 seconds vs 401 seconds), there were fewer episodes of multiple needle punctures (0 vs 2), multiple needle passes (2 vs 5), and attending interventions (0 vs 3) in the experimental group. No significant/clinical difference was found in pain during procedure, pain after procedure, patient satisfaction, or practitioner subjective difficulty.ConclusionsThis pilot study demonstrates that ultrasound‐guided ITB refills may reduce time spent with the needle in the skin, number of needle punctures, number of needle passes, and frequency of attending intervention during trainee refilling of pumps that are difficult to access.

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Section: Discussionmentioning

confidence: 71%

Section: Discussionmentioning

confidence: 80%

Section: Discussionmentioning

confidence: 81%

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Ultrasound guidance versus landmark guidance for intrathecal baclofen pump refill: A randomized pilot study

Stone

Wei

Reger

2023

PM&R

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“…The RFP can be clearly located as a hypoechoic rectangle between the hyperechoic lines of the metallic pump. It has been proven that the ultrasound-guided ITB pump refill method reduces procedure-related pain and increases patient satisfaction, even though it lengthened the duration of refills compared to the template-guided method [ 11 ].…”

Section: Discussionmentioning

confidence: 99%

Ultrasound-Guided Intrathecal Baclofen Pump Refilling Method for Management of Spasticity in a Complex Clinical Case

Pinho¹,

Anabela²,

Calado³

et al. 2022

Cureus

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Intrathecal baclofen (ITB) administration is a common method in managing spasticity. The location of the reservoir fill port (RFP) is identified manually in most cases. However, it can be difficult due to a variety of factors, such as the formation of excess subcutaneous cellular tissue and scar formation overlying the RFP and rotation or inversion of the pump. Consequently, multiple failed attempts accessing the reservoir increases pain and risk of fatal complications (e.g., infection and withdrawal syndrome from pocket filling). We describe a successful ultrasound-guided pump refilling case after multiple failed attempts by the conventional method. This groundbreaking instrument assists this minimally invasive procedure while limiting iatrogenic injury in the treatment of spasticity. The presentation of this case shows the utility of ultrasound as an important tool to guide the procedure and prevent adverse events in a spasticity management consult.

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“…In our study, there were seven cases of IDDS pocket fill during refill. A recent study showed that patients preferred ultrasoundguided refill as they were associated with less pain than template guided procedures (14). Ultrasound-guided refills took longer, and the safety events were similar in both the groups.…”

Section: Reporting Of Ae Associated With Iddsmentioning

confidence: 95%

Adverse Events and Complications Associated With Intrathecal Drug Delivery Systems: Insights From the Manufacturer and User Facility Device Experience (MAUDE) Database

Goel

Yan

Kanwar

et al. 2021

Neuromodulation: Technology at the Neural Interface

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A Comparison of Refill Procedures and Patient Outcomes Following Ultrasound-Guided and Template-Guided Intrathecal Drug Delivery Systems With Recessed Ports

Cited by 4 publications

References 18 publications

Ultrasound guidance versus landmark guidance for intrathecal baclofen pump refill: A randomized pilot study

Ultrasound guidance versus landmark guidance for intrathecal baclofen pump refill: A randomized pilot study

Ultrasound-Guided Intrathecal Baclofen Pump Refilling Method for Management of Spasticity in a Complex Clinical Case

Adverse Events and Complications Associated With Intrathecal Drug Delivery Systems: Insights From the Manufacturer and User Facility Device Experience (MAUDE) Database

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