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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04467359
Other study ID # 2018180520
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date March 31, 2022

Study information

Verified date October 2020
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This study aims to apply rapid rehabilitation nursing concept to the arthroscopic perioperative nursing, used to make up for the blank in this field, provides the reference for the overwhelming majority of peer, prompt the arthroscopic perioperative rehabilitation nursing development, accelerate the patient rehabilitation in January 2020 - December 2020 in Beijing a third rate sports medicine hospital be in hospital, to line the arthroscopic surgery patients as the research object, adopt the method of prospective, randomized, controlled in 220 patients. Inclusion criteria: < 60 age 18 years old, patients with informed consent and voluntary participation in arthroscopic anterior cruciate ligament reconstruction under external anesthesia were excluded from this study: patients with mental system diseases 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 tract disease research object were randomly divided into experimental group and control group, control group given conventional perioperative nursing, the experimental group to implement rapid rehabilitation program, the specific implementation process, see table 1 and table 2, compare two groups of preoperative postoperative self-care ability score (Barthel index) 、 the degree of postoperative pain numerical rating scale (NRS 0-10 score) 、the degree of comfort (Likert 1-5 rating score) and rehabilitation completion -Range of motion(ROM) score difference; 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 erythrocyte sedimentation rate(ESR)、C-reactive protein(CRP) and procalcitonin indexes in blood routine


Recruitment information / eligibility

Status Completed
Enrollment 172
Est. completion date March 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Arthroscopic anterior cruciate ligament reconstruction was performed under epidural anesthesia - The patients consented and volunteered to participate in this study Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ERAS
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.
Perioperative routine rehabilitation nursing
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

Locations

Country Name City State
China Peking Universitu 3rd Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary Rehabilitation Completion Range of motion(ROM):Use a square to measure the Angle of motion 2 weeks after discharged
Primary Rehabilitation Completion Range of motion(ROM):Use a square to measure the Angle of motion 4 weeks after discharged
Primary Rehabilitation Completion Range of motion(ROM):Use a square to measure the Angle of motion 8 weeks after discharged
Primary Rehabilitation Completion Range of motion(ROM):Use a square to measure the Angle of motion 12 weeks after discharged
Secondary adverse reaction Postoperative nausea, vomiting, dizziness, headache, urinary retention and other non-reaction occurred postoperative 1 day
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