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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06382896
Other study ID # FirstAHXiamenU-YB-2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source The First Affiliated Hospital of Xiamen University
Contact Bin Yang, doctor
Phone 13859986036
Email yangbin4332@outlook.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 320
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
This was an observational study

Locations

Country Name City State
China First Affiliated Hospital of Xiamen University Xiamen Fujian

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time of onset of postoperative rebound pain The numerical rating scale was used Within 48 hours after surgery
Primary The duration of the rebound pain The numerical rating scale was used Within 48 hours after surgery
Primary The degree of the rebound pain The numerical rating scale was used Within 48 hours after surgery
Primary age Fill in the postoperative questionnaire Within 48 hours after surgery
Primary sex Fill in the postoperative questionnaire Within 48 hours after surgery
Primary Surgical procedure Fill in the postoperative questionnaire Within 48 hours after surgery
Primary Previous surgical history Fill in the postoperative questionnaire Within 48 hours after surgery
Secondary Movement recovery time Fill in the postoperative questionnaire Within 7 days of surgery
See also
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