ERAS Protocol for Single-level Posterior Lumbar Arthrodesisprospective Study.

ERAS Protocol for Single-level Posterior Lumbar Arthrodesis; a Randomized Prospective Study

Enhanced Recovery After Surgery (ERAS) is a multidisciplinary, multimodal approach aiming to improve surgical outcomes. This study compares the length of hospital stay of patients undergoing single-level posterior lumbar arthrodesis and treated with the ERAS protocol with the hospital stay of patients treated according to the standard protocol.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use; Mobility; Instable Spine
• Intervention / Treatment: Other: Multimodal, multidisciplinary approach

Detailed Description

Hundred and ten patients scheduled for single-level posterior lumbar arthrodesis (PLIA) will be randomized to be treated by the standard protocol or the Enhanced Recovery After Surgery (ERAS) protocol. The ERAS protocol differs from the standard protocol in 4 phases: pre-operative counseling and intake, day of surgery, the pre-operative patient preparation, the per-operatively used analgesic and anesthetic drug combination, and the post-operative care consisting of a more intensive physical therapy in the ERAS group. It is the objective the mobilize patients more rapidly without compromising the comfort in terms of pain.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Erik Van de Kelft, MD, PhD; Phone Number: +32 3 760 21 72; Email: Erik.VandeKelft@aznikolaas.be
• Study Contact Backup: Name: Peter Verelst, MD; Phone Number: +32 3 760 85 48; Email: Peter.Verelst@aznikolaas.be

Study Locations

• Belgium
  • Sint-Niklaas, Belgium, 9100
    • Recruiting
    • AZ Nikolaas
    • Contact: Erik Van de Kelft, MD, PhD; Phone Number: +32 3 760 21 72; Email: Erik.VandeKelft@aznikolaas.be
    • Contact: Peter Verelst, MD; Phone Number: +32 3 760 85 48; Email: Peter.Verelst@aznikolaas.ve

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Scheduled for a single level PLIA as treatment of mono segmental degenerative instability, as seen on dynamic X-rays, after the failure of 6 months conservative therapy Capable of understanding the provided information Giving informed consent

Exclusion Criteria:

• Revision surgery Arthrodesis for trauma, neoplasms, infection, or listhesis due to lysis. High dose opioid use (step 3 of the WHO pain ladder) Diabetes Cognitive impairment (baseline dementia, cognitive dysfunction, or inability to consent to participate).

Known kidney insufficiency: GFR <30 mL/min/1.73 m2 Allergy/intolerance/contraindication to any medication or component included in the ERAS pathway protocol Patients with a risk factor for reflux

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ERAS group; Posterior lumbar interbody fusion Multimodal, multidisciplinary patient care.	Other: Multimodal, multidisciplinary approach; The patient management is adapted pre-operatively, per-operatively and post-operatively; Other Names: standard treatment
Active Comparator: Standard group; Posterior lumbar interbody fusion Standard treatment pre-, per-, and post-operative	Other: Multimodal, multidisciplinary approach; The patient management is adapted pre-operatively, per-operatively and post-operatively; Other Names: standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Number of days hospitalization	2-3 days + 11 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	pain intensity on the day of discharge, measured on a 11-point numeric rating scale	day of discharge
Analgesic use, including opioids	type and dose of analgesics used	2-3
11-days readmission rate	patients who return to the hospital for reasons linked to the recovery after surgery	discharge + 11 days

Collaborators and Investigators

• Sponsor: AZ Nikolaas

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: opioid use; Enhanced recovery after surgery (ERAS); Posterior lumbar Interbody arthrodesis (PLIA); length of hospital stay (LOS)
• Other Study ID Numbers: ERAS for PLIA 2020-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No