- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04467359
Application of Rapid Rehabilitation Nursing in Perioperative Rehabilitation of Knee Arthroscopy
October 9, 2022 updated by: Peking University Third Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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
Study Type
Interventional
Enrollment (Actual)
172
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China
- Peking Universitu 3rd Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: The experimental group
ERAS intervention group
|
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.
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
|
PLACEBO_COMPARATOR: The control group
Sports medicine rehabilitation nursing 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-care ability score
Time Frame: 1 day before operation
|
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
Time Frame: Postoperative 1 day
|
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
Time Frame: Postoperative 1 day
|
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
Time Frame: Postoperative 1 day
|
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
Time Frame: 2 weeks after discharged
|
Range of motion(ROM):Use a square to measure the Angle of motion
|
2 weeks after discharged
|
Rehabilitation Completion
Time Frame: 4 weeks after discharged
|
Range of motion(ROM):Use a square to measure the Angle of motion
|
4 weeks after discharged
|
Rehabilitation Completion
Time Frame: 8 weeks after discharged
|
Range of motion(ROM):Use a square to measure the Angle of motion
|
8 weeks after discharged
|
Rehabilitation Completion
Time Frame: 12 weeks after discharged
|
Range of motion(ROM):Use a square to measure the Angle of motion
|
12 weeks after discharged
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adverse reaction
Time Frame: postoperative 1 day
|
Postoperative nausea, vomiting, dizziness, headache, urinary retention and other non-reaction occurred
|
postoperative 1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xin Wang, Peking University Third Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2020
Primary Completion (ACTUAL)
December 31, 2021
Study Completion (ACTUAL)
March 31, 2022
Study Registration Dates
First Submitted
June 28, 2020
First Submitted That Met QC Criteria
July 9, 2020
First Posted (ACTUAL)
July 13, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 12, 2022
Last Update Submitted That Met QC Criteria
October 9, 2022
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2018180520
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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