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Study was unable to meet patient enrollment goals. PI chose to terminate the study early.
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This is a study comparing pain control utlilizing one or two epidural catheters, along with a hydromorphone PCA, for analgesia following surgery for correction of scoliosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single epidural catheter | Active Comparator |
| |
| double epidural catheter | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epidural catheter | Drug | epidural catheter with 0.3% ropivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores With Activity | The pain scores will be examined using the Numeric Rating Scale (NRS). NRS score ranges from 0-10. Higher score represents more pain/worse outcome | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores at Rest | The pain scores will be examined using the Numeric Rating Scale (NRS). NRS score ranges from 0-10. Higher score represents more pain/worse outcome | 72 hours |
| Opioid Usage | Hydromorphone usage measured in mcg/kg/day. No min/max. More hydromorphone usage represents worse outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Family Children's Hospital | Madison | Wisconsin | 53792 | United States |
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2 participants were enrolled in the study. However,this study was being closed due to difficulty with enrollment and changes to standard of care. No data was analysed for outcome measures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Epidural Catheter | |
| FG001 | Double Epidural Catheter |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Epidural Catheter | |
| BG001 | Double Epidural Catheter | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Scores With Activity | The pain scores will be examined using the Numeric Rating Scale (NRS). NRS score ranges from 0-10. Higher score represents more pain/worse outcome | This study is being closed due to difficulty with enrollment and changes to standard of care. No participant data was collected for outcome measures | Posted | 72 hours |
|
This study is being closed due to difficulty with enrollment and changes to standard of care. No adverse event data was collected
This study is being closed due to difficulty with enrollment and changes to standard of care.No adverse event data was collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Epidural Catheter | This study is being closed due to difficulty with enrollment and changes to standard of care. No data on serious adverse events was collected |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin J. Walker, MD | University of Wisconsin School of Medicine and Public Health | 608/262-8858 | bjwalker2@wisc.edu |
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| 72 hours |
| Functional Outcomes:The Pediatric Outcomes Data Collection Instrument (PODCI) Score | Functional outcome will be measured by the Pediatric Outcomes Data Collection Instrument (PODCI). Scores range from 0-100, lower score represents higher degree of disability | 3 months |
| Functional Outcomes: Scoliosis Research Society-22r (SRS-22r) Patient Questionnaire | Functional outcome will be measured by the Scoliosis Research Society-22r (SRS-22r). Scores range from 0-110, higher scores represent less disability/better outcome | 3 months |
| Functional Outcomes: The Owestry Disability Index(ODI) | Functional outcome will be measured by the Owestry Disability Index (ODI). ODI represents following disability levels: 0% -20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms. | 3 months |
Total of all reporting groups
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | Pain Scores at Rest | The pain scores will be examined using the Numeric Rating Scale (NRS). NRS score ranges from 0-10. Higher score represents more pain/worse outcome | This study is being closed due to difficulty with enrollment and changes to standard of care. No participant data was collected for outcome measures | Posted | 72 hours |
|
|
| Secondary | Opioid Usage | Hydromorphone usage measured in mcg/kg/day. No min/max. More hydromorphone usage represents worse outcome | This study is being closed due to difficulty with enrollment and changes to standard of care.No data analyses was done | Posted | 72 hours |
|
|
| Secondary | Functional Outcomes:The Pediatric Outcomes Data Collection Instrument (PODCI) Score | Functional outcome will be measured by the Pediatric Outcomes Data Collection Instrument (PODCI). Scores range from 0-100, lower score represents higher degree of disability | This study is being closed due to difficulty with enrollment and changes to standard of care.No data analyses was done | Posted | 3 months |
|
|
| Secondary | Functional Outcomes: Scoliosis Research Society-22r (SRS-22r) Patient Questionnaire | Functional outcome will be measured by the Scoliosis Research Society-22r (SRS-22r). Scores range from 0-110, higher scores represent less disability/better outcome | This study is being closed due to difficulty with enrollment and changes to standard of care.No data analyses was done | Posted | 3 months |
|
|
| Secondary | Functional Outcomes: The Owestry Disability Index(ODI) | Functional outcome will be measured by the Owestry Disability Index (ODI). ODI represents following disability levels: 0% -20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms. | This study is being closed due to difficulty with enrollment and changes to standard of care.No data analyses was done | Posted | 3 months |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Double Epidural Catheter | This study is being closed due to difficulty with enrollment and changes to standard of care. No data on serious adverse events was collected | 0 | 0 | 0 | 0 | 0 | 0 |
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