Adolescent Idiopathic Scoliosis
Conditions
Brief summary
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.
Interventions
epidural catheter with 0.3% ropivacaine
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing surgery via a posterior approach for AIS 2. Children ages 11-18 3. ASA physical status 1-2 4. Informed consent by legal guardian and assent by patient (for minors 11-17 years of age) or informed consent by subject (for patients 18 years of age) 5. Planned correction of at least 8 vertebral levels
Exclusion criteria
1. Patient refusal to participate 2. Patients on chronic narcotic medication 3. Allergy to standard of care drugs used in the study (Omnipaque, ropivacaine, hydromorphone, oxycodone, acetaminophen, gabapentin, ondansetron, nalbuphine or diphenhydramine, diazepam) 4. Coagulopathy 5. Pre-existing neurological deficit 6. Inability to use a Numerical Rating Scale (NRS: 0-10 patient self-reported score) for pain assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores With Activity | 72 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores at Rest | 72 hours | 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 |
| Opioid Usage | 72 hours | Hydromorphone usage measured in mcg/kg/day. No min/max. More hydromorphone usage represents worse outcome |
| Functional Outcomes:The Pediatric Outcomes Data Collection Instrument (PODCI) Score | 3 months | 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 |
| Functional Outcomes: Scoliosis Research Society-22r (SRS-22r) Patient Questionnaire | 3 months | 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 |
| Functional Outcomes: The Owestry Disability Index(ODI) | 3 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Single Epidural Catheter | 1 |
| Double Epidural Catheter | 1 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | study was closed due to low enrollment | 1 | 1 |
Baseline characteristics
| Characteristic | Single Epidural Catheter | Double Epidural Catheter | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: 72 hours
Population: This study is being closed due to difficulty with enrollment and changes to standard of care. No participant data was collected for outcome measures
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
Time frame: 3 months
Population: This study is being closed due to difficulty with enrollment and changes to standard of care.No data analyses was done
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.
Time frame: 3 months
Population: This study is being closed due to difficulty with enrollment and changes to standard of care.No data analyses was done
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
Time frame: 3 months
Population: This study is being closed due to difficulty with enrollment and changes to standard of care.No data analyses was done
Secondary
Opioid Usage
Hydromorphone usage measured in mcg/kg/day. No min/max. More hydromorphone usage represents worse outcome
Time frame: 72 hours
Population: This study is being closed due to difficulty with enrollment and changes to standard of care.No data analyses was done
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
Time frame: 72 hours
Population: This study is being closed due to difficulty with enrollment and changes to standard of care. No participant data was collected for outcome measures