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

September 5, 2023 updated by: RenJi Hospital

Feasibility Study of Peripheral Venous Cannulation Pain in Predicting Acute Pain After

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.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

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

Cohorts and Interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative resting pain and movement-evoked pain
Time Frame: 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
one hour、the first day and the second day after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 (Estimated)

August 30, 2023

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

August 16, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • taoliqin0730

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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