ERAS Protocol for Single-level Posterior Lumbar Arthrodesisprospective Study.

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05022745
• Other study ID #: ERAS for PLIA 2020-12
• Status: Recruiting
• Phase: Phase 4
• Start date: July 8, 2021
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: AZ Nikolaas
• Contact: Erik Van de Kelft, MD, PhD
• Phone: +32 3 760 21 72
• Email: Erik.vandeKelft[@]aznikolaas.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mobility
• Opioid Use

Intervention

Other:
• Multimodal, multidisciplinary approach
The patient management is adapted pre-operatively, per-operatively and post-operatively

Locations

Country	Name	City	State
Belgium	AZ Nikolaas	Sint-Niklaas

Sponsors (1)

Lead Sponsor	Collaborator
AZ Nikolaas

Country where clinical trial is conducted

Belgium, 

Outcome

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