Single vs Double Epidural Catheter Analgesia for Scoliosis Surgery

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

Single Versus Double Epidural Catheter Technique for Postoperative Analgesia Following Scoliosis Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01900626
• Other study ID #: 2013-0109
• Status: Terminated
• Phase: N/A
• Start date: July 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Drug:
• epidural catheter
epidural catheter with 0.3% ropivacaine

Locations

Country	Name	City	State
United States	American Family Children's Hospital	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	72 hours
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	72 hours
Secondary	Opioid Usage	Hydromorphone usage measured in mcg/kg/day. No min/max. More hydromorphone usage represents worse outcome	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	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	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.	3 months