ERAS Protocol for Single-level Posterior Lumbar Arthrodesisprospective Study.

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05022745

Enrollment

110

Registered

2021-08-26

Start date

2021-07-08

Completion date

2022-12-31

Last updated

2021-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Instable Spine, Mobility, Opioid Use

Keywords

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

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.

Interventions

OTHERMultimodal, multidisciplinary approach

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

The interventions described in the patient information brochure make masking impossible

Intervention model description

Randomized controlled study in patients undergoing PLIA

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Belgium

Contacts

Primary ContactErik Van de Kelft, MD, PhD

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

Backup ContactPeter Verelst, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026