Single vs Double Epidural Catheter Analgesia for Scoliosis Surgery

University of Wisconsin (UW)

Status: Terminated

Conditions: Adolescent Idiopathic Scoliosis

Treatments: Drug: epidural catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01900626

2013-0109

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 11 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

single epidural catheter

Active Comparator group

Treatment:

Drug: epidural catheter

double epidural catheter

Active Comparator group

Treatment:

Drug: epidural catheter