Clinical Trials Directory

Trials / Completed

CompletedNCT04962256

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
Phase
Study type
Observational
Enrollment
204 (actual)
Sponsor
Peking University Third Hospital · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREEnhanced recovery after surgeryERAS 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.

Timeline

Start date
2019-03-20
Primary completion
2022-03-31
Completion
2022-03-31
First posted
2021-07-14
Last updated
2022-10-12

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT04962256. Inclusion in this directory is not an endorsement.