Complex Spine Enhanced Recovery After Surgery (ERAS)

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Terminated

Conditions

Scoliosis Idiopathic

Treatments

Other: Enhanced Recovery After Surgery Protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT04538092
20-1705

Details and patient eligibility

About

In the field of Adult Spinal Deformity (ASD), there are currently no standardized protocols for preoperative, intraoperative or post-operative care. New standards are being created for minimally invasive spine surgery within orthopedics and some neurosurgical centers. This study will evaluate the efficacy of an Enhanced Recovery After Surgery protocol for complex spine surgery performed for the treatment of ASD.

Full description

Purpose : In the field of Adult Spinal Deformity (ASD), there are currently no standardized protocols for preoperative, intraoperative or post-operative care. New standards are being created for minimally invasive spine surgery within orthopedics and some neurosurgical centers. This study will evaluate the efficacy of an Enhanced Recovery After Surgery protocol for complex spine surgery performed for the treatment of ASD. Participants : Patients undergoing surgery aimed at treating adult spinal deformity are the subject of this research. This population was chosen as these procedures are often associated with prolonged length of stay (LOS), high post-operative narcotic use, and often require complex post-operative discharge planning. Procedures : Patients undergoing surgery to address the complications of ASD present a unique challenge in that this patient population is diverse, and there are multiple operative procedures available to treat the same condition. Given that there are currently no accepted or recommended Enhanced Recovery After Surgery protocols for complex spine procedures, the investigators have developed an ERAS protocol at the University of North Carolina (UNC) in collaboration with the anesthesia department for the support of complex surgical patients. Hypothesis: Implementing a multi-modal enhanced recovery after complex spine surgery protocol will improve patient measured outcomes and patient functional outcomes leading to a statistically significant reduction in LOS, post-operative pain, complication rate, cost.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with a diagnosis of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) Scoliosis (M41.9) category.
  • Patients undergoing a > 5 level arthrodesis using one of the following Current Procedural Terminology (CPT) coded procedures 22534, 22585, 22614, 22632, 22634 with either 22842, 22853
  • Cobb angle > 10 degrees
  • Failure of 3 months of conservative management

Exclusion criteria

  • Prior scoliosis surgery not performed at UNC Chapel Hill Hospital Facilities
  • Deformity correction due to trauma
  • History of neoplastic spine disease
  • Patients with active osteomyelitis
  • Patients with prior cement augmentation.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Control
No Intervention group
Description:
Standard post op complex spine orders placed for patients undergoing deformity correction
ERAS
Experimental group
Description:
Enhanced recovery after surgery protocol is applied to the patients undergoing deformity correction
Treatment:
Other: Enhanced Recovery After Surgery Protocol

Trial contacts and locations

1

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Central trial contact

Andrew L Abumoussa, MD MSc

Data sourced from clinicaltrials.gov

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