Clinical Trials Directory

Trials / Terminated

TerminatedNCT04538092

Complex Spine Enhanced Recovery After Surgery (ERAS)

Single Institution Prospective Analysis of an Enhanced Recovery After Complex Spine Surgery Protocol

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
University of North Carolina, Chapel Hill · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHEREnhanced Recovery After Surgery ProtocolThe investigators have developed an Enhanced Recovery After Surgery protocol for complex spine surgery at UNC. This study will help elucidate the effects of multiple interventions tailored to help patients recover from complex surgery.

Timeline

Start date
2020-09-14
Primary completion
2023-11-01
Completion
2023-11-01
First posted
2020-09-03
Last updated
2023-11-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04538092. Inclusion in this directory is not an endorsement.