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Feasibility Study of Peripheral Venous Cannulation Pain in Predicting Acute Pain After Total Knee Arthroplasty

Sponsor
RenJi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06002724
Collaborator
(none)
180
Enrollment
12.7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this prospective observational study is to explore the feasibility of preoperative peripheral venous cannulation pain score in predicting acute pain after total knee arthroplasty, including resting pain and movement-evoked pain.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    180 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Feasibility Study of Peripheral Venous Cannulation Pain in Predicting Acute Pain After
    Anticipated Study Start Date :
    Aug 10, 2023
    Anticipated Primary Completion Date :
    Aug 30, 2024
    Anticipated Study Completion Date :
    Aug 30, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    0

    Outcome Measures

    Primary Outcome Measures

    1. postoperative resting pain and movement-evoked pain [one hour、the first day and the second day after operation]

      visual analogue scale（VAS) of one hour、the first day and the second day after operation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Patients undergoing the first unilateral total knee arthroplasty surgery under general anesthesia combined with nerve block ;

    2. Age : 18 years old ≤ age ≤ 80 years old ;

    3. ASA grade I-II ;

    4. Informed consent was signed by patients or immediate family members before operation.

    Exclusion Criteria:

    1. There are known pain abnormalities, mental disorders, cognitive dysfunction ;

    2. patients with long-term use of opioids and a history of drug dependence ;

    3. patients with alcohol dependence ;

    4. the patient refused to use the analgesic pump ;

    5. Difficult to understand the VAS score ;

    6. body mass index ≥ 40 ;

    7. hand nerve abnormalities, hand loss ;

    8. plan postoperative ICU patients ;

    9. In other cases, the researchers believe that is not suitable for this researcher.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT06002724
    Other Study ID Numbers:
    • taoliqin0730
    First Posted:
    Aug 21, 2023
    Last Update Posted:
    Aug 21, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acute Pain

    Study Results

    No Results Posted as of Aug 21, 2023