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Determining the Prognostic Value of Continuous Intrathecal Infusion

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ClinicalTrials.gov Identifier: NCT03523000
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Salim M Hayek, University Hospitals Cleveland Medical Center

Brief Summary:

The purpose of this study will be to determine the efficacy and the prognostic value of a continuous intrathecal prognostic infusion test in an in-hospital setting for selecting patients who would have better long term outcomes for treatment with intrathecal implantable devices. The investigators will compare the primary outcomes [changes in pain intensity score (NRS), patient global impression of change (PGIC)] before and after intrathecal infusion of an admixture of bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml versus normal saline.

The study will include 36 patients with intractable chronic low back pain in the setting of lumbar post-laminectomy syndrome or vertebral compression fracture who failed conservative management and are considered candidates for IDDS.

Prior to the implant, the patients will undergo an intrathecal prognostic infusion test with an externalized catheter. Baseline NRS pain scores will be assessed and documented on all patients upon admission to the preoperative area. An intrathecal catheter will be placed in the outpatient procedure suite at the appropriate level for target dermatomes. The needle entry point will occur in the upper lumbar spine and catheter tip will be placed in the lower thoracic spine, under local anesthesia with the patient awake and with minimal or no sedation. The intrathecal infusion will be started using an external pump once patient is in the PACU. The research component is to perform the intrathecal test with normal saline (inactive placebo solution) in addition to a test with fentanyl and bupivacaine (active solution). Patients will be randomly assigned to either Group I (continuous infusion of bupivacaine and fentanyl followed by saline) or Group II (continuous infusion of saline followed by bupivacaine and fentanyl).

In PACU, patients will be started on an infusion rate of 0.5 ml/hr and titrated to pain relief greater than 50% of baseline or up to 0.8-1.0 ml/hr within 6-8 hrs after start of the infusion. A clinician blinded to the treatment arm will assess NRS and PGIC on the patients after approximately 12 hours. Assessment will include changes in pain intensity score at rest and upon ambulating or performing maneuvers that normally elicit patient's low back pain. A 4-6-hour washout period will be allotted with infusion of preservative-free normal saline at a rate of 0.2 ml/hr, after which the physician will document a return of the NRS to baseline before switching therapies.


Condition or disease Intervention/treatment Phase
Lumbar Post-Laminectomy Syndrome Chronic Low Back Pain Vertebral Compression Fracture Failed Back Surgery Syndrome Other: Continuous intrathecal prognostic infusion test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Patients who are considered candidates for intrathecal pump implant fulfilling the inclusion/exclusion criteria and who elect to participate in the study will be randomly assigned to two groups:

Group A tested with continuous infusion of intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml for 14-18 hours followed by a trial with normal saline for another 14-18 hours; separated by a 4-6-hr infusion of preservative-free saline.

Group B tested with intrathecal normal saline for 14-18 hours followed by intrathecal Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml for another 14-18 hours; separated by a 4-6-hr infusion of preservative-free saline.

Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The drugs will be delivered by the pharmacy to a blinded physician and labeled as Intrathecal solution 1 and Intrathecal solution 2 to be administered sequentially, separated by a 4-6-hr infusion of preservative-free saline. The content of Intrathecal solution 1 and 2 will be unknown to all investigators and participants in the study with the exception of the investigational pharmacy. The order of the Intrathecal solution (1 or 2) will be determined by pharmacy using a computer generated random sequence allocation.
Primary Purpose: Treatment
Official Title: A Randomized Double Blind Cross-over Trial of Continuous Intrathecal Infusion for Assessing Patients With Chronic Non-cancer Pain Who Would Benefit From Treatment With Intrathecal Drug Delivery System (IDDS) Implant
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Arm Intervention/treatment
Active Comparator: Active Solution
Continuous intrathecal prognostic infusion test of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml
Other: Continuous intrathecal prognostic infusion test
The patient is infused with solution through the percutaneous intrathecal catheter at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours

Placebo Comparator: Inactive Placebo Solution
Continuous intrathecal prognostic infusion test of inactive placebo solution: preservative-free normal saline
Other: Continuous intrathecal prognostic infusion test
The patient is infused with solution through the percutaneous intrathecal catheter at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours




Primary Outcome Measures :
  1. Change in numerical rating scale pain scores (NRS) [ Time Frame: Comparing change in NRS from baseline (Day 1) to: end of intrathecal infusion of solution 1 (Day 2), end of intrathecal infusion of solution 2 (Day 3), 6-month post-implant clinic follow up, 12-month post-implant clinic follow up ]
    Numerical Rating Scale is an 11-point pain scale whereby 0 signifies no pain and 10 the worse pain ever


Secondary Outcome Measures :
  1. Change in Oswestry Disability Score (ODI) [ Time Frame: Comparing change in ODI from baseline (Day 1) to: end of intrathecal infusion of solution 2 (Day 3), 6-month post-implant clinic follow up, 12-month post-implant clinic follow up ]
    ODI is a scored 10 questions outcome measure designed to realize how the back or leg pain is affecting the patient's ability to manage in everyday life.

  2. Change in painDETECT [ Time Frame: Comparing change in PainDETECT from baseline (Day 1) to: end of intrathecal infusion of solution 2 (Day 3), 6-month post-implant clinic follow up, 12-month post-implant clinic follow up ]
    The painDETECT questionnaire was specifically developed to detect neuropathic pain components in adult patients with low back pain

  3. Change in Patient Global Impression of Change (PGIC) [ Time Frame: Comparing change in PGIC from baseline (Day 1) to: end of intrathecal infusion of solution 1 (Day 2), end of intrathecal infusion of solution 2 (Day 3), 6-month post-implant clinic follow up, 12-month post-implant clinic follow u ]
    PGIC is a rated 7-point scale to assess the overall treatment response.

  4. Treatment Satisfaction Questionnaire (TSQ) [ Time Frame: Comparing change in TSQ from baseline (Day 1) to: end of intrathecal infusion of solution 1 (Day 2), end of intrathecal infusion of solution 2 (Day 3), 6-month post-implant clinic follow up, 12-month post-implant clinic follow up ]
    TSQ is a questionnaire to rate level of satisfaction or dissatisfaction with the Intrathecal Drug Delivery

  5. Adverse Event (AE) [ Time Frame: Assessing any AEs that occur from baseline (Day 1) through the 12-month post-implant clinic follow up ]
    AE is any untoward medical occurrence in the patient which does not necessarily have a causal relationship with this infusion treatment

  6. Change in medication [ Time Frame: Assessing any changes in pain medications from baseline (Day 1) through the 12-month post-implant clinic follow up ]
    Any increases or decreases in the dose or frequency of pain medication



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous lumbar or thoracic spine surgery or lower thoracic/lumbar vertebral compression fracture
  • Intractable pain of trunk (more than limbs)
  • Patient who passed psychological evaluations as part of the usual clinical care prior to consideration of IDDS and are stable with current pain condition and medications
  • Failed more conservative management.

Exclusion Criteria:

  • Untreated coagulopathy or infection.
  • Immune compromised state precluding having an implant.
  • Allergic reactions to bupivacaine or fentanyl.
  • Pregnancy
  • Patients using more than 30 mg oral equivalents of morphine daily or who are unable to wean down below that dosage for more than 4 weeks before the prognostic intrathecal infusion test.
  • Neurological deficits characterized as weakness in lower extremities with evidence of nerve damage
  • Patients with cognitive disorders who would not be able to provide meaningful outcome responses

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523000


Contacts
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Contact: Mario A Becerra, RN 216) 844-1734 Mario.Becerra@UHhospitals.org
Contact: Sheree White, RN 216) 286-0761 Sheree.White@UHhospitals.org

Locations
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United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Clinical Research Specialist    216-844-3771    Stephanie.Madercic@UHhospitals.org   
Principal Investigator: Salim Hayek, MD         
Sub-Investigator: Melinda Lawrence, MD         
Sub-Investigator: Al Amin Khalil, MD         
Sub-Investigator: Ankit Maheshwari, MD         
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Salim Hayek, MD University Hospitals Cleveland Medical Center
  Study Documents (Full-Text)

Documents provided by Salim M Hayek, University Hospitals Cleveland Medical Center:
Informed Consent Form  [PDF] June 30, 2017

Publications:

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Responsible Party: Salim M Hayek, Professor, Department of Anesthesiology/Chief, Division of Pain Medicine, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT03523000    
Other Study ID Numbers: 08-16-09
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Salim M Hayek, University Hospitals Cleveland Medical Center:
intractable chronic low back pain
lumbar post-laminectomy syndrome
vertebral compression fracture
intrathecal drug delivery system
Additional relevant MeSH terms:
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Syndrome
Back Pain
Low Back Pain
Failed Back Surgery Syndrome
Fractures, Compression
Disease
Pathologic Processes
Fractures, Bone
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Postoperative Complications