ERAS in Posterior Approach of Cervical Spine Operation

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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Myelopathy
• Intervention / Treatment: Procedure: Enhanced recovery after surgery

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Feifei Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with posterior approach of cervical spine operation

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Patients with degenerative CSM or OPLL undergoing C3-7 open-door laminoplasty	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2019
• Primary Completion (ACTUAL): March 31, 2022
• Study Completion (ACTUAL): March 31, 2022

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (ACTUAL): July 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 9, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Cervical Myelopathy; Enhanced recovery after surgery; Surgical outcome
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Spinal Cord Diseases; Bone Marrow Diseases
• Other Study ID Numbers: M2019144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No