ERAS in Posterior Approach of Cervical Spine Operation

Peking University Third Hospital204 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

204

Conditions

Cervical Myelopathy

Interventions

Enhanced recovery after surgeryPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients should be diagnosed as CSM based on the history, symptoms, Physical signs and radiographic results. 2. Patients did not respond to the 3-month conventional treatment. 3. Patients were performed posterior approach of cervical spine operation. 4. Patients should have complete pre- and post-operative data. Exclusion Criteria: 1. Patients with severe organic diseases. 2. Patients with previous history of cervical spine surgery. 3. Patients with mental or psychological abnormality. 4. Patients with severe osteoporosis (T value \<-2.5).

Locations (1)

Feifei Zhou

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Outcomes of pain

Visual analogue scale before after surgery, 0 to 10 points, higher means severer the pain is.

Time frame: Preoperation

Outcomes of pain

Visual analogue scale 3-month after surgery, 0 to 10 points, higher means severer the pain is.

Time frame: 3 months after surgery.

Length of stay

Time frame: 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.

Time frame: Preoperation

Neurological function

Modified Japanese Orthopaedic Association score 3-month after surgery, -2 to 17 points, higher means better outcome.

Time frame: 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.

Time frame: Preoperation

Outcomes of quality of life

36-Item Short Form Survey score 3-month after surgery, 0 to 100 points, higher means better outcome.

Time frame: 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.

Time frame: Admission to discharge, an average of 3 days

Data from ClinicalTrials.gov

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