Patient Controlled Intrathecal Analgesia With Bupivacaine for Chronic Low Back Pain
Pain, Intractable, Breakthrough Pain, Chronic Pain
About this trial
This is an interventional treatment trial for Pain, Intractable
Eligibility 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
Sites / Locations
- University Hospitals Case Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Bupivacaine + Opioid
Opioid
Intrathecal solution has bupivacaine with an opioid (hydromorphone, fentanyl or morphine). Patients will administer PTM bolus of bupivacaine with opioid. The bolus will be administered over 2 minutes and will have a variable frequency depending on patient's need but the number of boluses should be >2 and <10. The bupivacaine dosage would range between 0.4 and 1.5 mg per bolus. The opioid dose will vary depending on the concentration of the opioid in the solution.
Intrathecal solution has only an opioid (hydromorphone, fentanyl or morphine) and no bupivacaine. Patients will administer PTM bolus of opioid without bupivacaine. This opioid bolus dose would be the same as they would have received prior to enrolling in the study (with bupivacaine). The bolus will be administered over 2 minutes and will have a variable frequency depending on patient's need but the number of boluses should be >2 and <10.