ERAS in Posterior Approach of Cervical Spine Operation

Cervical Myelopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04962256
• Other study ID #: M2019144
• Status: Completed
• Start date: March 20, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: October 2022
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Cervical Myelopathy
• Spinal Cord Diseases

Intervention

Procedure:
• Enhanced recovery after surgery
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.

Locations

Country	Name	City	State
China	Feifei Zhou	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcomes of pain	Visual analogue scale before after surgery, 0 to 10 points, higher means severer the pain is.	Preoperation
Primary	Outcomes of pain	Visual analogue scale 3-month after surgery, 0 to 10 points, higher means severer the pain is.	3 months after surgery.
Primary	Length of stay	Length of stay	Admission to discharge, an average of 3 days
Primary	Neurological function	Modified Japanese Orthopaedic Association score before surgery, -2 to 17 points, higher means better outcome.	Preoperation
Primary	Neurological function	Modified Japanese Orthopaedic Association score 3-month after surgery, -2 to 17 points, higher means better outcome.	3 months after surgery.
Primary	Outcomes of quality of life	36-Item Short Form Survey score before surgery, 0 to 100 points, higher means better outcome.	Preoperation
Primary	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
Primary	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
Primary	Personal interviews	Personal interviews of patients at 3-month follow-up	At 3-month follow-up