Trial Outcomes & Findings for Determining the Prognostic Value of Continuous Intrathecal Infusion (NCT NCT03523000)
NCT ID: NCT03523000
Last Updated: 2023-01-12
Results Overview
Numerical Rating Scale is an 11-point pain scale whereby 0 signifies no pain and 10 the worse pain ever
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
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)
Results posted on
2023-01-12
Participant Flow
Participant milestones
| Measure |
Active Solution Followed by Inactive Placebo Solution
Continuous intrathecal prognostic infusion test of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml
6 hour washout followed by
Continuous intrathecal prognostic infusion test of inactive placebo solution: preservative-free normal saline
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
Bupivacaine: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Fentanyl: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Placebo: Intrathecal infusion of normal saline at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Intrathecal Drug Delivery System (IDDS): 40-mL IDDS containing a solution of fentanyl 50 mcg/mL with bupivacaine 30 mg/mL
|
Inactive Placebo Solution Followed by Active Solution
First Intervention: Continuous infusion of placebo solution: normal saline at a rate of 0.5-1.0mL/hr for another 14-18 hour.
Washout: 4-6 hr washout infusion of preservative-free saline0.2 mL/hr. Second Intervention: Continuous infusion of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml at a rate of 0.5-1.0 mL/hr for 14-18 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
16
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Active Solution Followed by Inactive Placebo Solution
Continuous intrathecal prognostic infusion test of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml
6 hour washout followed by
Continuous intrathecal prognostic infusion test of inactive placebo solution: preservative-free normal saline
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
Bupivacaine: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Fentanyl: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Placebo: Intrathecal infusion of normal saline at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Intrathecal Drug Delivery System (IDDS): 40-mL IDDS containing a solution of fentanyl 50 mcg/mL with bupivacaine 30 mg/mL
|
Inactive Placebo Solution Followed by Active Solution
First Intervention: Continuous infusion of placebo solution: normal saline at a rate of 0.5-1.0mL/hr for another 14-18 hour.
Washout: 4-6 hr washout infusion of preservative-free saline0.2 mL/hr. Second Intervention: Continuous infusion of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml at a rate of 0.5-1.0 mL/hr for 14-18 hours.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Unsuccessful trial
|
2
|
0
|
Baseline Characteristics
Determining the Prognostic Value of Continuous Intrathecal Infusion
Baseline characteristics by cohort
| Measure |
All Study Participants
n=36 Participants
All participants participated in all interventions so for the baseline characteristics all participants were combined into one arm/group.
|
|---|---|
|
Age, Continuous
|
63.5 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)Numerical Rating Scale is an 11-point pain scale whereby 0 signifies no pain and 10 the worse pain ever
Outcome measures
| Measure |
Active Solution Followed by Inactive Placebo Solution
n=15 Participants
Continuous intrathecal prognostic infusion test of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml
6 hour washout followed by
Continuous intrathecal prognostic infusion test of inactive placebo solution: preservative-free normal saline
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
Bupivacaine: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Fentanyl: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Placebo: Intrathecal infusion of normal saline at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Intrathecal Drug Delivery System (IDDS): 40-mL IDDS containing a solution of fentanyl 50 mcg/mL with bupivacaine 30 mg/mL
|
Inactive Placebo Solution Followed by Active Solution
n=16 Participants
First Intervention: Continuous infusion of placebo solution: normal saline at a rate of 0.5-1.0mL/hr for another 14-18 hour.
Washout: 4-6 hr washout infusion of preservative-free saline0.2 mL/hr. Second Intervention: Continuous infusion of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml at a rate of 0.5-1.0 mL/hr for 14-18 hours.
|
|---|---|---|
|
Change in Numerical Rating Scale Pain Scores (NRS) With Activity
Baseline
|
8.40 Score on a scale
Standard Deviation 1.64
|
8.00 Score on a scale
Standard Deviation 1.6
|
|
Change in Numerical Rating Scale Pain Scores (NRS) With Activity
End of intrathecal infusion of solution (Day 2)
|
4.13 Score on a scale
Standard Deviation 3.58
|
4.19 Score on a scale
Standard Deviation 2.61
|
|
Change in Numerical Rating Scale Pain Scores (NRS) With Activity
End of intrathecal infusion of solution (Day 3)
|
4.38 Score on a scale
Standard Deviation 2.53
|
6.73 Score on a scale
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: 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)Numerical Rating Scale is an 11-point pain scale whereby 0 signifies no pain and 10 the worse pain ever
Outcome measures
| Measure |
Active Solution Followed by Inactive Placebo Solution
n=15 Participants
Continuous intrathecal prognostic infusion test of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml
6 hour washout followed by
Continuous intrathecal prognostic infusion test of inactive placebo solution: preservative-free normal saline
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
Bupivacaine: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Fentanyl: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Placebo: Intrathecal infusion of normal saline at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Intrathecal Drug Delivery System (IDDS): 40-mL IDDS containing a solution of fentanyl 50 mcg/mL with bupivacaine 30 mg/mL
|
Inactive Placebo Solution Followed by Active Solution
n=16 Participants
First Intervention: Continuous infusion of placebo solution: normal saline at a rate of 0.5-1.0mL/hr for another 14-18 hour.
Washout: 4-6 hr washout infusion of preservative-free saline0.2 mL/hr. Second Intervention: Continuous infusion of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml at a rate of 0.5-1.0 mL/hr for 14-18 hours.
|
|---|---|---|
|
Change in Numerical Rating Scale Pain Scores (NRS) at Rest
Baseline
|
6.5 Score on a scale
Standard Deviation 2.69
|
6.75 Score on a scale
Standard Deviation 2.04
|
|
Change in Numerical Rating Scale Pain Scores (NRS) at Rest
End of intrathecal infusion of solution (Day 2)
|
3.67 Score on a scale
Standard Deviation 3.33
|
3.69 Score on a scale
Standard Deviation 2.52
|
|
Change in Numerical Rating Scale Pain Scores (NRS) at Rest
End of intrathecal infusion of solution (Day 3)
|
4.25 Score on a scale
Standard Deviation 2.77
|
6.73 Score on a scale
Standard Deviation 2.52
|
SECONDARY outcome
Timeframe: Comparing change in ODI from baseline (Day 1) to: end of intrathecal infusion of solution 2 (Day 3)Oswestry Disability Index (ODI) This scale based on a questionnaire of activities measures the impact of pain on multiple factors within a patient's daily life. Higher values represent worse outcomes, or a higher impact from pain on the patient's daily life. The total score range is 0-50. Subcategories include: 0-4: no disability. 5-14: mild disability. 15-24: moderate disability. 25-34: sever disability. 35-50: completely disabled.
Outcome measures
| Measure |
Active Solution Followed by Inactive Placebo Solution
n=15 Participants
Continuous intrathecal prognostic infusion test of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml
6 hour washout followed by
Continuous intrathecal prognostic infusion test of inactive placebo solution: preservative-free normal saline
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
Bupivacaine: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Fentanyl: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Placebo: Intrathecal infusion of normal saline at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Intrathecal Drug Delivery System (IDDS): 40-mL IDDS containing a solution of fentanyl 50 mcg/mL with bupivacaine 30 mg/mL
|
Inactive Placebo Solution Followed by Active Solution
n=16 Participants
First Intervention: Continuous infusion of placebo solution: normal saline at a rate of 0.5-1.0mL/hr for another 14-18 hour.
Washout: 4-6 hr washout infusion of preservative-free saline0.2 mL/hr. Second Intervention: Continuous infusion of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml at a rate of 0.5-1.0 mL/hr for 14-18 hours.
|
|---|---|---|
|
Change in Oswestry Disability Score (ODI)
Baseline
|
27.13 score on a scale
Standard Deviation 5.91
|
26.81 score on a scale
Standard Deviation 5.88
|
|
Change in Oswestry Disability Score (ODI)
End of intrathecal infusion of solution (Day 3)
|
20.38 score on a scale
Standard Deviation 8.42
|
27.07 score on a scale
Standard Deviation 9.76
|
SECONDARY outcome
Timeframe: Comparing change in PainDETECT from baseline (Day 1) to: end of intrathecal infusion of solution 2 (Day 3)The painDETECT questionnaire was specifically developed to detect neuropathic pain components in adult patients with low back pain. PainDETECT is a scale of 0 to 35, with 0 being no disability to 35 being max disability.
Outcome measures
| Measure |
Active Solution Followed by Inactive Placebo Solution
n=15 Participants
Continuous intrathecal prognostic infusion test of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml
6 hour washout followed by
Continuous intrathecal prognostic infusion test of inactive placebo solution: preservative-free normal saline
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
Bupivacaine: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Fentanyl: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Placebo: Intrathecal infusion of normal saline at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Intrathecal Drug Delivery System (IDDS): 40-mL IDDS containing a solution of fentanyl 50 mcg/mL with bupivacaine 30 mg/mL
|
Inactive Placebo Solution Followed by Active Solution
n=16 Participants
First Intervention: Continuous infusion of placebo solution: normal saline at a rate of 0.5-1.0mL/hr for another 14-18 hour.
Washout: 4-6 hr washout infusion of preservative-free saline0.2 mL/hr. Second Intervention: Continuous infusion of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml at a rate of 0.5-1.0 mL/hr for 14-18 hours.
|
|---|---|---|
|
Change in painDETECT Total
Baseline
|
15.047 score on a scale
Standard Deviation 9.28
|
11.94 score on a scale
Standard Deviation 7.78
|
|
Change in painDETECT Total
End of intrathecal infusion of solution (Day 3)
|
10.19 score on a scale
Standard Deviation 8.03
|
14.27 score on a scale
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: Comparing change in PainDETECT from baseline (Day 1) to: end of intrathecal infusion of solution 2 (Day 3)The painDETECT questionnaire was specifically developed to detect neuropathic pain components in adult patients with low back pain. PainDETECT is a scale 0 to 38, with 0 being no disability to 38 being max disability.
Outcome measures
| Measure |
Active Solution Followed by Inactive Placebo Solution
n=15 Participants
Continuous intrathecal prognostic infusion test of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml
6 hour washout followed by
Continuous intrathecal prognostic infusion test of inactive placebo solution: preservative-free normal saline
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
Bupivacaine: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Fentanyl: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Placebo: Intrathecal infusion of normal saline at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Intrathecal Drug Delivery System (IDDS): 40-mL IDDS containing a solution of fentanyl 50 mcg/mL with bupivacaine 30 mg/mL
|
Inactive Placebo Solution Followed by Active Solution
n=16 Participants
First Intervention: Continuous infusion of placebo solution: normal saline at a rate of 0.5-1.0mL/hr for another 14-18 hour.
Washout: 4-6 hr washout infusion of preservative-free saline0.2 mL/hr. Second Intervention: Continuous infusion of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml at a rate of 0.5-1.0 mL/hr for 14-18 hours.
|
|---|---|---|
|
Change in painDETECT Final
Baseline
|
16.4 score on a scale
Standard Deviation 9.76
|
13.31 score on a scale
Standard Deviation 8.72
|
|
Change in painDETECT Final
End of intrathecal infusion of solution (Day 3)
|
10.81 score on a scale
Standard Deviation 7.99
|
15.27 score on a scale
Standard Deviation 9.92
|
SECONDARY outcome
Timeframe: Comparing change in PGIC from end of intrathecal infusion of solution 1 (Day 2), to end of intrathecal infusion of solution 2 (Day 3)Patient Global Impression of Change (PGIC) scale is a seven-point single-item scale ranging from 7 'very much worse' to 1 'very much improved'.
Outcome measures
| Measure |
Active Solution Followed by Inactive Placebo Solution
n=15 Participants
Continuous intrathecal prognostic infusion test of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml
6 hour washout followed by
Continuous intrathecal prognostic infusion test of inactive placebo solution: preservative-free normal saline
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
Bupivacaine: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Fentanyl: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Placebo: Intrathecal infusion of normal saline at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Intrathecal Drug Delivery System (IDDS): 40-mL IDDS containing a solution of fentanyl 50 mcg/mL with bupivacaine 30 mg/mL
|
Inactive Placebo Solution Followed by Active Solution
n=16 Participants
First Intervention: Continuous infusion of placebo solution: normal saline at a rate of 0.5-1.0mL/hr for another 14-18 hour.
Washout: 4-6 hr washout infusion of preservative-free saline0.2 mL/hr. Second Intervention: Continuous infusion of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml at a rate of 0.5-1.0 mL/hr for 14-18 hours.
|
|---|---|---|
|
Change in Patient Global Impression of Change (PGIC)
End of intrathecal infusion of solution (Day 2)
|
4.53 score on a scale
Standard Deviation 0.74
|
4.66 score on a scale
Standard Deviation 1.11
|
|
Change in Patient Global Impression of Change (PGIC)
End of intrathecal infusion of solution (Day 3)
|
4.07 score on a scale
Standard Deviation 2.05
|
2.48 score on a scale
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: Up to one yearPopulation: All participants were analyzed together for this outcome.
TSQ is a questionnaire to rate level of satisfaction or dissatisfaction with the Intrathecal Drug Delivery- patients were asked preference for either intrathecal solution. Patient preferences for each solution were measured. This data represents the total number of patient's that received a trial and the total number of patients who preferred each solution. Higher values indicate a greater number of study participants preferred a specific arm. Patients with no preference are listed separately.
Outcome measures
| Measure |
Active Solution Followed by Inactive Placebo Solution
n=31 Participants
Continuous intrathecal prognostic infusion test of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml
6 hour washout followed by
Continuous intrathecal prognostic infusion test of inactive placebo solution: preservative-free normal saline
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
Bupivacaine: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Fentanyl: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Placebo: Intrathecal infusion of normal saline at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Intrathecal Drug Delivery System (IDDS): 40-mL IDDS containing a solution of fentanyl 50 mcg/mL with bupivacaine 30 mg/mL
|
Inactive Placebo Solution Followed by Active Solution
First Intervention: Continuous infusion of placebo solution: normal saline at a rate of 0.5-1.0mL/hr for another 14-18 hour.
Washout: 4-6 hr washout infusion of preservative-free saline0.2 mL/hr. Second Intervention: Continuous infusion of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml at a rate of 0.5-1.0 mL/hr for 14-18 hours.
|
|---|---|---|
|
Treatment Satisfaction Questionnaire (TSQ)
Intrathecal Infusion 1- Sequence 1
|
11 Participants
|
—
|
|
Treatment Satisfaction Questionnaire (TSQ)
Intrathecal Infusion 2- Sequence 1
|
2 Participants
|
—
|
|
Treatment Satisfaction Questionnaire (TSQ)
No preference- Sequence1
|
2 Participants
|
—
|
|
Treatment Satisfaction Questionnaire (TSQ)
Intrathecal Infusion 1- Sequence 2
|
5 Participants
|
—
|
|
Treatment Satisfaction Questionnaire (TSQ)
Intrathecal Infusion 2- Sequence 2
|
11 Participants
|
—
|
|
Treatment Satisfaction Questionnaire (TSQ)
No preference- Sequence 2
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Assessing any AEs that occur from baseline (Day 1) through the 12-month post-implant clinic follow upPopulation: Deaths and Adverse Events were not collected per intervention
AE is any untoward medical occurrence in the patient which does not necessarily have a causal relationship with this infusion treatment
Outcome measures
| Measure |
Active Solution Followed by Inactive Placebo Solution
n=31 Participants
Continuous intrathecal prognostic infusion test of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml
6 hour washout followed by
Continuous intrathecal prognostic infusion test of inactive placebo solution: preservative-free normal saline
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
Bupivacaine: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Fentanyl: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Placebo: Intrathecal infusion of normal saline at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Intrathecal Drug Delivery System (IDDS): 40-mL IDDS containing a solution of fentanyl 50 mcg/mL with bupivacaine 30 mg/mL
|
Inactive Placebo Solution Followed by Active Solution
First Intervention: Continuous infusion of placebo solution: normal saline at a rate of 0.5-1.0mL/hr for another 14-18 hour.
Washout: 4-6 hr washout infusion of preservative-free saline0.2 mL/hr. Second Intervention: Continuous infusion of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml at a rate of 0.5-1.0 mL/hr for 14-18 hours.
|
|---|---|---|
|
Adverse Event (AE)
|
9 Adverse events
|
—
|
SECONDARY outcome
Timeframe: Assessing any changes in pain medications from baseline (Day 1) through the 12-month post-implant clinic follow upNumber of participants that had increases or decreases in the dose or frequency of pain medication
Outcome measures
| Measure |
Active Solution Followed by Inactive Placebo Solution
n=15 Participants
Continuous intrathecal prognostic infusion test of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml
6 hour washout followed by
Continuous intrathecal prognostic infusion test of inactive placebo solution: preservative-free normal saline
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
Bupivacaine: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Fentanyl: Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Placebo: Intrathecal infusion of normal saline at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
Intrathecal Drug Delivery System (IDDS): 40-mL IDDS containing a solution of fentanyl 50 mcg/mL with bupivacaine 30 mg/mL
|
Inactive Placebo Solution Followed by Active Solution
n=16 Participants
First Intervention: Continuous infusion of placebo solution: normal saline at a rate of 0.5-1.0mL/hr for another 14-18 hour.
Washout: 4-6 hr washout infusion of preservative-free saline0.2 mL/hr. Second Intervention: Continuous infusion of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml at a rate of 0.5-1.0 mL/hr for 14-18 hours.
|
|---|---|---|
|
Change in Medication
|
0 Participants
|
3 Participants
|
Adverse Events
All Study Participants
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Study Participants
n=31 participants at risk
Deaths and Adverse Events were not collected per intervention. All participants participated in all interventions. All participants were combined into one group for the adverse event tracking.
|
|---|---|
|
General disorders
Left lower extremity pain
|
3.2%
1/31 • Number of events 1 • 12 months
|
|
General disorders
Exacerbation of low back pain
|
3.2%
1/31 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Urinary retention
|
3.2%
1/31 • Number of events 1 • 12 months
|
|
General disorders
Transient headache
|
3.2%
1/31 • Number of events 4 • 12 months
|
|
General disorders
post-dural puncture headache
|
3.2%
1/31 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
diarrhea requiring loperamide
|
3.2%
1/31 • Number of events 1 • 12 months
|
Additional Information
Dr. Salim Hayek
University Hospitals Cleveland Medical Center
Phone: 216-844-2685
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place