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Enhanced Recovery After Spine Surgery Randomized Clinical Trial (ERASS)

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University of Pennsylvania

Status

Completed

Conditions

ERAS

Treatments

Other: ERASS Pathway

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this study is to compare two different approaches to the care patients receive before, during and after their spinal surgery and to determine if either approach has a significant difference in patient outcomes, opioid use, and recovery following spine surgery. The study will compare the standard-of-care surgical approach taken at the Hospital of the University of Pennsylvania with the Enhanced Recovery After Spine Surgery (ERASS) pathway. ERASS is a program that will provide additional education before your surgery, reduce your opioid consumption, and provide earlier physical therapy than you would normally receive under the standard-of-care approach, among other protocols outlined in this consent. Patients will be randomized to receive either of these approaches and the researchers will collect information to better understand if the ERASS approach provides more patient benefits.

Enrollment

284 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients 18 and older (both male and female), who present to the department of neurosurgery at the Hospital of the University of Pennsylvania and who are determined to require elective spine surgery with one of two senior spine neurosurgeons, Drs. Malhotra and Marcotte.

Exclusion criteria

  • Patients who are pregnant
  • Incarceration
  • Patients under the age of 18
  • Patients unable to participate in the consent procedure
  • Patients undergoing emergent surgery
  • Patients with liver disease

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

284 participants in 2 patient groups

Control
No Intervention group
Treatment
Experimental group
Treatment:
Other: ERASS Pathway

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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