NCT04467359

Brief Summary

The purpose of this study is to apply the concept of rapid rehabilitation nursing in the perioperative period of knee arthroscopy, to make up for the gap in this field, to provide reference basis for the general colleagues, promote the development of perioperative rapid rehabilitation nursing of knee arthroscopy, accelerate the rehabilitation of patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2020

Enrollment Period

1.3 years

First QC Date

June 28, 2020

Last Update Submit

October 9, 2022

Conditions

Keywords

NursingEnhanced Recovery After Surgery(ERAS)

Outcome Measures

Primary Outcomes (8)

  • Self-care ability score

    Barthel Index:Barthel index is scored from 0 to 100. A score of 100 indicates that the patient has a good function in basic daily activities. He/she does not need help from others. He/she is able to control urine and urine, eat, dress, transfer to bed and chair, bathe, walk for at least one block, and can go up and down stairs. A score of 0 indicates poor functioning, lack of independence, and need help with all aspects of daily life. According to the score of Barthel index, the ability of daily activities was divided into three levels: good, medium and poor \>. 60 was classified as good. 60 to 41 is medium. Have moderate dysfunction and need great help to complete daily activities; ≤40 is classified as poor, with severe dysfunction, most daily activities cannot be completed or need to be attended to by others.

    1 day before operation

  • Self-care ability score

    Barthel Index:Barthel index is scored from 0 to 100. A score of 100 indicates that the patient has a good function in basic daily activities. He/she does not need help from others. He/she is able to control urine and urine, eat, dress, transfer to bed and chair, bathe, walk for at least one block, and can go up and down stairs. A score of 0 indicates poor functioning, lack of independence, and need help with all aspects of daily life. According to the score of Barthel index, the ability of daily activities was divided into three levels: good, medium and poor \>. 60 was classified as good. 60 to 41 is medium. Have moderate dysfunction and need great help to complete daily activities; ≤40 is classified as poor, with severe dysfunction, most daily activities cannot be completed or need to be attended to by others.

    Postoperative 1 day

  • Degree of postoperative pain

    Numerical Rating Scale(NRS )score:0 means no pain, 10 means the most severe pain imaginable, and the higher the score, the more severe the pain

    Postoperative 1 day

  • Comfort level

    Likert 1-5 score:0 means very uncomfortable, 10 means very comfortable, and the higher the score, the higher the comfort

    Postoperative 1 day

  • Rehabilitation Completion

    Range of motion(ROM):Use a square to measure the Angle of motion

    2 weeks after discharged

  • Rehabilitation Completion

    Range of motion(ROM):Use a square to measure the Angle of motion

    4 weeks after discharged

  • Rehabilitation Completion

    Range of motion(ROM):Use a square to measure the Angle of motion

    8 weeks after discharged

  • Rehabilitation Completion

    Range of motion(ROM):Use a square to measure the Angle of motion

    12 weeks after discharged

Secondary Outcomes (1)

  • adverse reaction

    postoperative 1 day

Study Arms (2)

The experimental group

EXPERIMENTAL

ERAS intervention group

Other: ERASOther: Perioperative routine rehabilitation nursing

The control group

PLACEBO COMPARATOR

Sports medicine rehabilitation nursing group

Other: Perioperative routine rehabilitation nursing

Interventions

ERASOTHER

Optimize physical conditions; Fasting solid diet 6h before surgery, fasting clear fluid 2 h before surgery; If there is no chief complaint of dizziness, nausea or other discomfort after the operation, warm water (no more than 100ml) can be immediately drunk. Pain management; Encourage patients to engage in early activities under the premise of effective pain control; If no dural puncture and other complications occur, the patient has no chief complaints of headache, dizziness, nausea and other discomfort, and there is no need to lie supine, the comfortable position such as semi-supine lateral supine position can be taken immediately (avoid 90-degree upright position for patients with hip joint); Prevention of thrombosis; Prevention and treatment of nausea and vomiting; Follow-up was conducted at 4 weeks, 8 weeks and 12 weeks after the operation.

The experimental group

Fasting and water deprivation at 12 o 'clock on the first day before surgery; Fasting water 6-8 hours after surgery; Lie flat on your pillow for 6 hours; Get out of bed activity 1 day after operation

The control groupThe experimental group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Arthroscopic anterior cruciate ligament reconstruction was performed under epidural anesthesia
  • The patients consented and volunteered to participate in this study

You may not qualify if:

  • Patients with mental disorders or communication disorders
  • Patients with metabolic diseases such as diabetes
  • Patients who could not quit smoking and drinking alcohol before surgery as required
  • Patients with gastrointestinal disorders
  • Patients who are not under epidural anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Universitu 3rd Hospital

Beijing, China

Location

Study Officials

  • Xin Wang

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The subjects were randomly divided into the experimental group and the control group. The control group received conventional rehabilitation nursing during the perioperative period, while the experimental group received ERAS intervention. The differences between the two groups in postoperative pain degree (NRS0-10) comfort level (Likert 1-5) and rehabilitation completion Range of motion(ROM) score were compared. The safety index was the occurrence of postoperative complications such as nausea, vomiting, dizziness, headache and urinary retention, and the occurrence of postoperative complications such as hypothermia after lower extremity deep venous thrombosis (preoperative and postoperative comparison of ESR CRP and procalcitonin indexes in blood routine)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2020

First Posted

July 13, 2020

Study Start

September 1, 2020

Primary Completion

December 31, 2021

Study Completion

March 31, 2022

Last Updated

October 12, 2022

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations