ERAS Protocol for Single-level Posterior Lumbar Arthrodesisprospective Study.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mobility, Opioid Use, Instable Spine

Intervention / Treatment
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* Other: Multimodal, multidisciplinary approach


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled study in patients undergoing PLIA
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enhanced recovery after surgery (ERAS), Posterior lumbar Interbody arthrodesis (PLIA), length of hospital stay (LOS), opioid use