Adolescent Idiopathic ScoliosisNCT01900626
Single vs Double Epidural Catheter Analgesia for Scoliosis Surgery
A study testing epidural catheter in people with Adolescent Idiopathic Scoliosis, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- epidural catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients undergoing surgery via a posterior approach for AIS
- Children ages 11-18
- ASA physical status 1-2
- 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)
- Planned correction of at least 8 vertebral levels
Who cannot join
- Patient refusal to participate
- Patients on chronic narcotic medication
- Allergy to standard of care drugs used in the study (Omnipaque, ropivacaine, hydromorphone, oxycodone, acetaminophen, gabapentin, ondansetron, nalbuphine or diphenhydramine, diazepam)
- Coagulopathy
- Pre-existing neurological deficit
- Inability to use a Numerical Rating Scale (NRS: 0-10 patient self-reported score) for pain assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
American Family Children's Hospital
Madison, Wisconsin, 53792
About this study
Official title: Single Versus Double Epidural Catheter Technique for Postoperative Analgesia Following Scoliosis Surgery
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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- epidural catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural catheterDrug
epidural catheter with 0.3% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| single epidural catheter | Active comparator | Not described Receives: Drug: epidural catheter |
| double epidural catheter | Active comparator | Not described Receives: Drug: epidural catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours
Secondary outcomes (5)
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
Measured: 72 hours
Opioid Usage
Hydromorphone usage measured in mcg/kg/day. No min/max. More hydromorphone usage represents worse outcome
Measured: 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
Measured: 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
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Study was unable to meet patient enrollment goals. PI chose to terminate the study early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900626
- Sponsor's protocol ID
- 2013-0109
- Status last verified
- Apr 2019
- First submitted
- 11 Jul 2013
- Last updated
- 8 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Versus Double Epidural Catheter Technique for Postoperative Analgesia Following Scoliosis Surgery
- ClinicalTrials.gov ID
- NCT01900626
- Acronym / sponsor ID
- 2013-0109
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was unable to meet patient enrollment goals. PI chose to terminate the study early.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Posted 8 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single epidural catheter | Active comparator | Drug: epidural catheter |
| double epidural catheter | Active comparator | Drug: epidural catheter |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients undergoing surgery via a posterior approach for AIS
- Children ages 11-18
- ASA physical status 1-2
- 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)
- Planned correction of at least 8 vertebral levels
Key exclusion criteria (6 listed)
- Patient refusal to participate
- Patients on chronic narcotic medication
- Allergy to standard of care drugs used in the study (Omnipaque, ropivacaine, hydromorphone, oxycodone, acetaminophen, gabapentin, ondansetron, nalbuphine or diphenhydramine, diazepam)
- Coagulopathy
- Pre-existing neurological deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidural catheterepidural catheter with 0.3% ropivacaine | Drug | double epidural catheter, single epidural catheter |
Primary outcome
Pain Scores With Activity
Time frame: 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
5 secondary outcomes
Pain Scores at Rest
Time frame: 72 hours
Opioid Usage
Time frame: 72 hours
Functional Outcomes:The Pediatric Outcomes Data Collection Instrument (PODCI) Score
Time frame: 3 months
Functional Outcomes: Scoliosis Research Society-22r (SRS-22r) Patient Questionnaire
Time frame: 3 months
Functional Outcomes: The Owestry Disability Index(ODI)
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epidural catheter in people with Adolescent Idiopathic Scoliosis, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores With Activity (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.