CompletedPhase 4

Patient Controlled Intrathecal Analgesia With Bupivacaine for Chronic Low Back Pain

United States17 participantsStarted 2016-05

Plain-language summary

The purpose of this study is to determine whether the local anesthetic bupivacaine delivered intrathecally in small doses via PTM self-administered boluses significantly improves the breakthrough pain and functional status of patients with chronic intractable pain who are managed with an intrathecal drug delivery system.

Who can participate

Age range

31 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Age more than 30 years implanted with an intrathecal drug delivery device. * Intrathecal pump patients on stable dose for the last 3 months. * Using on average more than 2 and less than 10 PTM doses per day * Intrathecal medication admixture consisting of bupivacaine and another opioid (fentanyl or hydromorphone or morphine) Exclusion Criteria * Using 10 or more PTM bolus doses per day or 2 or less PTM bolus doses per day * Pending litigation or worker compensation claim * Any recent (less than 3 month) procedures in spine (surgeries) or catheter adjustments. * Recent pump dose adjustment within the past 3 months * Pumps with medications other than bupivacaine/opioid combination. * Pregnant or breast feeding

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in the Numerical Rating Pain Scale (NRS)

Timeframe: Before self-administered bolus using Patient Therapy Manager device (PTM) and within 30 minutes of PTM bolus

Trial details

NCT IDNCT02886286

SponsorUniversity Hospitals Cleveland Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12

Results submitted2021-10-06

View on ClinicalTrials.gov More Pain, Intractable trials