Patient Controlled Intrathecal Analgesia With Bupivacaine for Chronic Low Back Pain

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Treatments: Analgesics, Opioid; Bupivacaine; Fentanyl; Hydromorphone; Morphine

Criteria

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