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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERAS group | Experimental | Posterior lumbar interbody fusion Multimodal, multidisciplinary patient care. |
|
| Standard group | Active Comparator | Posterior lumbar interbody fusion Standard treatment pre-, per-, and post-operative |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal, multidisciplinary approach | Other | The patient management is adapted pre-operatively, per-operatively and post-operatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Number of days hospitalization | 2-3 days + 11 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erik Van de Kelft, MD, PhD | Contact | +32 3 760 21 72 | Erik.vandeKelft@aznikolaas.be | |
| Peter Verelst, MD | Contact | +32 3 760 85 48 | Peter.Verelst@aznikolaas.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Nikolaas | Recruiting | Sint-Niklaas | 9100 | Belgium |
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Randomized controlled study in patients undergoing PLIA
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The interventions described in the patient information brochure make masking impossible
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|
| 2-3 |
| 11-days readmission rate | patients who return to the hospital for reasons linked to the recovery after surgery | discharge + 11 days |