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NCT Number: NCT04962256

ERAS in Posterior Approach of Cervical Spine Operation

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.

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Key information

Conditions

Cervical Myelopathy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Feifei Zhou

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

Primary outcomes

  1. Outcomes of pain

    Time frame: Preoperation

    Visual analogue scale before after surgery, 0 to 10 points, higher means severer the pain is.

  2. Outcomes of pain

    Time frame: 3 months after surgery.

    Visual analogue scale 3-month after surgery, 0 to 10 points, higher means severer the pain is.

  3. Length of stay

    Time frame: Admission to discharge, an average of 3 days

    Length of stay

  4. Neurological function

    Time frame: Preoperation

    Modified Japanese Orthopaedic Association score before surgery, -2 to 17 points, higher means better outcome.

  5. Neurological function

    Time frame: 3 months after surgery.

    Modified Japanese Orthopaedic Association score 3-month after surgery, -2 to 17 points, higher means better outcome.

  6. Outcomes of quality of life

    Time frame: Preoperation

    36-Item Short Form Survey score before surgery, 0 to 100 points, higher means better outcome.

  7. Outcomes of quality of life

    Time frame: 3 months after surgery

    36-Item Short Form Survey score 3-month after surgery, 0 to 100 points, higher means better outcome.

  8. Focus group meetings

    Time frame: Admission to discharge, an average of 3 days

    Focus group meetings by specialists, to discuss the effect of ERAS and the what improvements can be made.

  9. Personal interviews

    Time frame: At 3-month follow-up

    Personal interviews of patients at 3-month follow-up

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 14, 2021
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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