NCT06002724

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

August 16, 2023

Last Update Submit

September 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • postoperative resting pain and movement-evoked pain

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

    one hour、the first day and the second day after operation

Study Arms (1)

0

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing unilateral total knee arthroplasty for the first time under general anesthesia combined with nerve block

You may qualify if:

  • Patients undergoing the first unilateral total knee arthroplasty surgery under general anesthesia combined with nerve block ;
  • Age : 18 years old ≤ age ≤ 80 years old ;
  • ASA grade I-II ;
  • Informed consent was signed by patients or immediate family members before operation.

You may not qualify if:

  • There are known pain abnormalities, mental disorders, cognitive dysfunction ;
  • patients with long-term use of opioids and a history of drug dependence ;
  • patients with alcohol dependence ;
  • the patient refused to use the analgesic pump ;
  • Difficult to understand the VAS score ;
  • body mass index ≥ 40 ;
  • hand nerve abnormalities, hand loss ;
  • plan postoperative ICU patients ;
  • In other cases, the researchers believe that is not suitable for this researcher.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 21, 2023

Study Start

August 30, 2023

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share