ERAS Protocol for Single-level Posterior Lumbar Arthrodesisprospective Study.

NCT05022745 | Unknown Phase 4 DMC

• 1 other identifier: ERAS for PLIA 2020-12
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mobility; Opioid Use; Instable Spine

Keywords

Enhanced recovery after surgery (ERAS); Posterior lumbar Interbody arthrodesis (PLIA); length of hospital stay (LOS); opioid use

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  Number of days hospitalization

  2-3 days + 11 days

Secondary Outcomes (3)

• Pain intensity

  day of discharge

• Analgesic use, including opioids

  2-3

• 11-days readmission rate

  discharge + 11 days

Study Arms (2)

ERAS group

EXPERIMENTAL

Posterior lumbar interbody fusion Multimodal, multidisciplinary patient care.

Other: Multimodal, multidisciplinary approach

Standard group

ACTIVE COMPARATOR

Posterior lumbar interbody fusion Standard treatment pre-, per-, and post-operative

Other: Multimodal, multidisciplinary approach

Interventions

Multimodal, multidisciplinary approach OTHER

The patient management is adapted pre-operatively, per-operatively and post-operatively

Also known as: standard treatment

ERAS group; Standard group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AZ Nikolaas: lead

Study Sites (1)

AZ Nikolaas

Sint-Niklaas, 9100, Belgium

RECRUITING

Central Study Contacts

Erik Van de Kelft, MD, PhD

CONTACT

+32 3 760 21 72; Erik.vandeKelft@aznikolaas.be

Peter Verelst, MD

CONTACT

+32 3 760 85 48; Peter.Verelst@aznikolaas.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The interventions described in the patient information brochure make masking impossible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of neurosurgery department

Model Details: Randomized controlled study in patients undergoing PLIA

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 26, 2021
• Study Start: July 8, 2021
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)