NCT06382896

Brief Summary

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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

April 15, 2024

Last Update Submit

April 23, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • Time of onset of postoperative rebound pain

    The numerical rating scale was used

    Within 48 hours after surgery

  • The duration of the rebound pain

    The numerical rating scale was used

    Within 48 hours after surgery

  • The degree of the rebound pain

    The numerical rating scale was used

    Within 48 hours after surgery

  • age

    Fill in the postoperative questionnaire

    Within 48 hours after surgery

  • sex

    Fill in the postoperative questionnaire

    Within 48 hours after surgery

  • Surgical procedure

    Fill in the postoperative questionnaire

    Within 48 hours after surgery

  • Previous surgical history

    Fill in the postoperative questionnaire

    Within 48 hours after surgery

Secondary Outcomes (1)

  • Movement recovery time

    Within 7 days of surgery

Study Arms (1)

Patients undergoing ambulatory arthroscopic knee surgery

Other: No intervention

Interventions

This was an observational study

Patients undergoing ambulatory arthroscopic knee surgery

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \. 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.

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

Central Study Contacts

Bin Yang, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 15, 2024

First Posted

April 24, 2024

Study Start

January 1, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations