Enhanced Recovery After Spine Surgery Randomized Clinical Trial

NCT ID: NCT05830331

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-18
• Study Completion Date: 2021-10-13

Brief Summary

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.

Conditions

ERAS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment

Group Type: EXPERIMENTAL

ERASS Pathway

Intervention Type: OTHER

Enhanced Recovery After Spinal Surgery

Interventions

ERASS Pathway

Enhanced Recovery After Spinal Surgery

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Zarina Ali

Chief, Penn Presbyterian Medical Center Department of Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zarina Ali, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Neil Malhotra, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

831303

Identifier Type: -

Identifier Source: org_study_id