ERAS in Posterior Approach of Cervical Spine Operation

NCT04962256 | Completed DMC

• 1 other identifier: M2019144
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Myelopathy

Keywords

Cervical Myelopathy; Enhanced recovery after surgery; Surgical outcome

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

Study group

Patients with degenerative CSM or OPLL undergoing C3-7 open-door laminoplasty

Procedure: Enhanced recovery after surgery

Interventions

Enhanced recovery after surgery PROCEDURE

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.

Study group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with posterior approach of cervical spine operation

You may qualify if:

• Patients should be diagnosed as CSM based on the history, symptoms, Physical signs and radiographic results.
• Patients did not respond to the 3-month conventional treatment.
• Patients were performed posterior approach of cervical spine operation.
• Patients should have complete pre- and post-operative data.

You may not qualify if:

• Patients with severe organic diseases.
• Patients with previous history of cervical spine surgery.
• Patients with mental or psychological abnormality.
• Patients with severe osteoporosis (T value \<-2.5).

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Feifei Zhou

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Interventions

Enhanced Recovery After Surgery

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 14, 2021
• Study Start: March 20, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)