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 range31 Years – 90 Years

SexALL

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

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