Phase 4
N=17
Patient Controlled Intrathecal Analgesia With Bupivacaine for Chronic Low Back Pain
Pain, Intractable · Breakthrough Pain · Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT02886286 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Change From Baseline in the Numerical Rating Pain Scale (NRS) — 1.87; 1.81 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bupivacaine (Drug); Opioid (Drug)
- Age
- Adult, Older Adult · 31+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Numerical Rating Pain Scale (NRS) |
1.87; 1.81 | — |
| SECONDARY Change From Baseline in Oswestry Disability Index (ODI) |
.88; 2.67 | — |
| SECONDARY Change From Baseline in Patient Global Impression of Change (PGIC) |
-0.06; 1.25 | — |
| SECONDARY Change From Baseline in painDETECT |
0.69; 0.25 | — |
| SECONDARY Change From Baseline in Average Weekly Numeric Pain Rating Score (NRS) |
-0.47; -0.38 | — |
| SECONDARY Change From Baseline in Treatment Satisfaction |
2.36; 1.94 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02886286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.