ERAS Protocol for Single-level Posterior Lumbar Arthrodesisprospective Study.

Phase 4

• Conditions: Instable Spine; Mobility; Opioid Use
• Interventions: Other: Multimodal, multidisciplinary approach

• Registration Number: NCT05022745
• Lead Sponsor: AZ Nikolaas

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.

Study Timeline

• Study Start: 2021-07-08
• Status Verified: 2021-08
• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-25
• Last Update Submitted: 2021-08-25
• Study First Posted: 2021-08-26
• Last Update Posted: 2021-08-26
• Primary Completion: 2022-08
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS group	Multimodal, multidisciplinary approach	Posterior lumbar interbody fusion Multimodal, multidisciplinary patient care.
Standard group	Multimodal, multidisciplinary approach	Posterior lumbar interbody fusion Standard treatment pre-, per-, and post-operative

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	2-3 days + 11 days	Number of days hospitalization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AZ Nikolaas; 🇧🇪 Sint-Niklaas, Belgium