Patient Controlled Intrathecal Analgesia With Bupivacaine for Chronic Low Back Pain

NCT02886286 | Completed Phase 4 Results DMC

• 1 other identifier: 2-16-24
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Intractable; Breakthrough Pain; Chronic Pain

Outcome Measures

Primary Outcomes (1)

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

  Patients will be provided with a diary to record pain scores just before a PTM bolus and the lowest pain score within half an hour after a PTM bolus. Numerical Rating Pain Scale (NRS): scale from 0-10 0 = no pain 10 = worst imaginable pain

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

Secondary Outcomes (5)

• Change From Baseline in Oswestry Disability Index (ODI)

  Day 0, 7, 14, score at day 7 or day 14 reported

• Change From Baseline in Patient Global Impression of Change (PGIC)

  Day 0, 7, 14, score at day 7 or day 14 reported

• Change From Baseline in painDETECT

  Day 0, 7, 14, score at day 7 or day 14 reported

• Change From Baseline in Average Weekly Numeric Pain Rating Score (NRS)

  Day 0, 7, 14, score at day 7 or day 14 reported

• Change From Baseline in Treatment Satisfaction

  Day 0, 7, 14, score at day 7 or day 14 reported

Study Arms (2)

Bupivacaine + Opioid

EXPERIMENTAL

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.

Drug: Bupivacaine; Drug: Opioid

Opioid

ACTIVE COMPARATOR

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.

Drug: Opioid

Interventions

Bupivacaine DRUG

Patient-activated intrathecal bolus for incident pain

Bupivacaine + Opioid

Opioid DRUG

Patient-activated intrathecal bolus for incident pain

Also known as: Fentanyl, Hydromorphone, Morphine

Bupivacaine + Opioid; Opioid

Eligibility Criteria

• Age: 31 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Pain, Intractable; Breakthrough Pain; Chronic Pain

Interventions

Bupivacaine; Analgesics, Opioid; Fentanyl; Hydromorphone; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Salim M. Hayek, MD, PhD
• Organization: University Hospitals Cleveland Medical Center

salim.hayek@uhhospitals.org

2168442685

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Chief, Division of Pain Medicine

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: September 1, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 24, 2022
• Results First Posted: March 24, 2022

Record last verified: 2022-02

Locations

US (1)