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Single vs Double Epidural Catheter Analgesia for Scoliosis Surgery

University of Wisconsin (UW) logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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