ERAS in Posterior Approach of Cervical Spine Operation

Study Overview
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Brief Summary
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Enhanced recovery after surgery (ERAS) strategy has been used in the patient management of different diseases. This study aims to evaluate the effectiveness of ERAS in the perioperative period of posterior approach of cervical spine operation among patients with CSM.

Detailed Description
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Enhanced recovery after surgery (ERAS) strategy has been used in the patient management of different diseases, but up to now, few effort has been done to evaluate the effectiveness of ERAS in patients perioperative management of cervical spine surgery. As a interdisciplinary cooperation system, either qualitative or quantitative method alone can not completely reflect the function of ERAS. Mixed model research (MMR) is a appropriate method to evaluate a complex system, but it has not been used in ERAS evaluation. This study aims to evaluate the effectiveness of ERAS in the perioperative period of posterior approach of cervical spine operation among patients with CSM using MMR, including the retrospective quantitative part and prospective qualitative part. In the retrospective part, we will collect the data of length of stay, VAS scores, mJOA scores and SF-36 scores to compare the difference between ERAS group and regular group. In the prospective part, we will collect the data from the focus group meetings and personal interviews of patients, to verify that ERAS has the ability to improve the postoperative outcomes, while maintain an equal surgical effect.

Official Title
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The Application of Enhanced Recovery After Surgery (ERAS) During the Perioperative Period of Patients With Posterior Approach of Cervical Spine Operation: a Mixed Methods Study

Conditions
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Cervical Myelopathy

Intervention / Treatment
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* Procedure: Enhanced recovery after surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients should be diagnosed as CSM based on the history, symptoms, Physical signs and radiographic results. Patients did not respond to the 3-month conventional treatment. Patients were performed posterior approach of cervical spine operation. Patients should have complete pre- and post-operative data. Exclusion Criteria: Patients with severe organic diseases. Patients with previous history of cervical spine surgery. Patients with mental or psychological abnormality. Patients with severe osteoporosis (T value <-2.5).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Patients with degenerative CSM or OPLL undergoing C3-7 open-door laminoplasty | Procedure: Enhanced recovery after surgery<br>* ERAS management includes 3 parts: (1) Preoperative analgesia and airway evaluation. (2) The protection and reconstruction of the musculo-ligamentous complex during the surgery, the safe intubation, and the local infiltration anesthesia during surgery. (3) Collar free, multimodal analgesia, airway management, and early recovery after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcomes of pain | Visual analogue scale before after surgery, 0 to 10 points, higher means severer the pain is. | Preoperation | 
| Outcomes of pain | Visual analogue scale 3-month after surgery, 0 to 10 points, higher means severer the pain is. | 3 months after surgery. | 
| Length of stay | Length of stay | Admission to discharge, an average of 3 days | 
| Neurological function | Modified Japanese Orthopaedic Association score before surgery, -2 to 17 points, higher means better outcome. | Preoperation | 
| Neurological function | Modified Japanese Orthopaedic Association score 3-month after surgery, -2 to 17 points, higher means better outcome. | 3 months after surgery. | 
| Outcomes of quality of life | 36-Item Short Form Survey score before surgery, 0 to 100 points, higher means better outcome. | Preoperation | 
| Outcomes of quality of life | 36-Item Short Form Survey score 3-month after surgery, 0 to 100 points, higher means better outcome. | 3 months after surgery | 
| Focus group meetings | Focus group meetings by specialists, to discuss the effect of ERAS and the what improvements can be made. | Admission to discharge, an average of 3 days | 
| Personal interviews | Personal interviews of patients at 3-month follow-up | At 3-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Myelopathy, Enhanced recovery after surgery, Surgical outcome