Effect of Oliceridine on Rebound Pain

April 23, 2024 updated by: Yang Bin, The First Affiliated Hospital of Xiamen University

A Clinical Study on the Effect of Oliceridine（TRV130） on Postoperative Rebound Pain and Early Rehabilitation Exercise After Knee Arthroscopy

The purpose of this clinical study was to identify the risk factors for postoperative pain outburst in patients undergoing arthroscopic knee surgery after Oliceridine and nerve block, and to evaluate the effect of oxeridine on early rehabilitation exercise in patients. A total of 320 patients undergoing arthroscopic knee arthroscopy under general anesthesia combined with femoral nerve block were selected to record the time and duration of postoperative pain outbreak, pain degree, age, gender, operation type, previous surgical history and other related risk factors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

320

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

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Recruiting
        • First Affiliated Hospital of Xiamen University
        • 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

No

Sampling Method

Non-Probability Sample

Study Population

General anesthesia combined with femoral nerve block was selected for knee arthroscopic day surgery

Description

Inclusion Criteria:

1. Age 18-70 years old;2. Body mass index (BMI) 18-30kg /m2;3. American Society of Anesthesiologists (ASA) Grade I to II;4. Hospital stay >24h.

Exclusion Criteria:

1. Patients who cannot understand the numerical rating scale score and give feedback;2. Known allergy to the drug in the study;3. Infection of puncture site with nerve block;4. Oral analgesics for more than 2 weeks before surgery;5. Long-term use of glucocorticoids;6. Simultaneous surgery on both limbs;7. A psychopath;8. Severe compound trauma;9. Pregnant and lactating women.

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

Group / Cohort
Intervention / Treatment
Patients undergoing ambulatory arthroscopic knee surgery
Other: No intervention
This was an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of onset of postoperative rebound pain
Time Frame: Within 48 hours after surgery
The numerical rating scale was used
Within 48 hours after surgery
The duration of the rebound pain
Time Frame: Within 48 hours after surgery
The numerical rating scale was used
Within 48 hours after surgery
The degree of the rebound pain
Time Frame: Within 48 hours after surgery
The numerical rating scale was used
Within 48 hours after surgery
age
Time Frame: Within 48 hours after surgery
Fill in the postoperative questionnaire
Within 48 hours after surgery
sex
Time Frame: Within 48 hours after surgery
Fill in the postoperative questionnaire
Within 48 hours after surgery
Surgical procedure
Time Frame: Within 48 hours after surgery
Fill in the postoperative questionnaire
Within 48 hours after surgery
Previous surgical history
Time Frame: Within 48 hours after surgery
Fill in the postoperative questionnaire
Within 48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Movement recovery time
Time Frame: Within 7 days of surgery
Fill in the postoperative questionnaire
Within 7 days of surgery

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital of Xiamen University

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)

January 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • FirstAHXiamenU-YB-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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