ERAS Protocol for Single-level Posterior Lumbar Arthrodesisprospective Study.

NCT ID: NCT05022745

Last Updated: 2021-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-08
• Study Completion Date: 2022-12-31

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.

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.

Conditions

Mobility; Opioid Use; Instable Spine

Study Design

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

Study Groups

ERAS group

Posterior lumbar interbody fusion Multimodal, multidisciplinary patient care.

Group Type: EXPERIMENTAL

Multimodal, multidisciplinary approach

Intervention Type: OTHER

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

Standard group

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

Group Type: ACTIVE_COMPARATOR

Multimodal, multidisciplinary approach

Intervention Type: OTHER

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

Interventions

Multimodal, multidisciplinary approach

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

Intervention Type: OTHER

Other Intervention Names

standard treatment

Eligibility Criteria

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

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

Sponsors

AZ Nikolaas

OTHER

Sponsor Role: lead

Responsible Party

Erik Van de Kelft, M.D., PhD

Head of neurosurgery department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AZ Nikolaas

Sint-Niklaas, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Erik Van de Kelft, MD, PhD

Role: CONTACT

Erik.vandeKelft@aznikolaas.be

+32 3 760 21 72

Peter Verelst, MD

Role: CONTACT

Peter.Verelst@aznikolaas.be

+32 3 760 85 48

Facility Contacts

Erik Van de Kelft, MD, PhD

Role: primary

Erik.VandeKelft@aznikolaas.be

+32 3 760 21 72

Peter Verelst, MD

Role: backup

Peter.Verelst@aznikolaas.ve

+32 3 760 85 48

Other Identifiers

ERAS for PLIA 2020-12

Identifier Type: -

Identifier Source: org_study_id