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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: The experimental group
ERAS intervention group
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.
Other: 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
PLACEBO_COMPARATOR: The control group
Sports medicine rehabilitation nursing group
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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