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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04962256
Enrollment
204
Registered
2021-07-14
Start date
2019-03-20
Completion date
2022-03-31
Last updated
2022-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Myelopathy

Keywords

Cervical Myelopathy, Enhanced recovery after surgery, Surgical outcome

Brief 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.

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.

Interventions

PROCEDUREEnhanced 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.

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years

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).

Design outcomes

Primary

MeasureTime frameDescription
Outcomes of painPreoperationVisual analogue scale before after surgery, 0 to 10 points, higher means severer the pain is.
Length of stayAdmission to discharge, an average of 3 daysLength of stay
Neurological functionPreoperationModified Japanese Orthopaedic Association score before surgery, -2 to 17 points, higher means better outcome.
Outcomes of quality of lifePreoperation36-Item Short Form Survey score before surgery, 0 to 100 points, higher means better outcome.
Focus group meetingsAdmission to discharge, an average of 3 daysFocus group meetings by specialists, to discuss the effect of ERAS and the what improvements can be made.
Personal interviewsAt 3-month follow-upPersonal interviews of patients at 3-month follow-up

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026