Efficacy and Safety of Oliceridine for Moderate to Severe Acute Pain After Orthopedic Surgery
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The goal of this clinical trial\] is to further explore the effectiveness and safety of oxelidine in the treatment of moderate to severe acute pain after orthopedic surgery. The main question it aims to answer is: Pain management after orthopaedic surgery provides more effective and safe drug options, provides new options for clinical treatment, and provides a scientific basis for clinical practice. Participants will be asked to pain score in the different time, treatments they'll be given and use optimal drug. Researchers will compare analgesic effect of oxelidine of different dose.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• elective orthopedic surgery under general anesthesia.
• The patient can communicate normally and has the correct expression of pain
Locations
Other Locations
China
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Yiwu
Contact Information
Primary
Dongmei Ma
8019111@zju.edu.cn
+8615267358077
Backup
Li Li
65602423@qq.com
+8618267858561
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 162
Treatments
Experimental: low dose oxelidine group
Oxelidine fumarate (10ml, 20mg) + normal saline 190ml diluted to 200ml. PCIA parameters were set as follows: background infusion rate was 0, self-controlled dosage was 0.35mg (3.5ml), locking time was 6min, and load was 1.5mg
Experimental: high dose oxelidine group
Oxelidine fumarate (10ml, 20mg) + normal saline 190ml diluted to 200ml. PCIA parameters were set as follows: background infusion rate was 0, self-controlled dosage was 0.5mg (5ml), locking time was 6min, and load was 1.5mg
Active_comparator: hydromorphone group
Hydromorphone (6ml, 12mg) + normal saline (194ml) diluted to 200ml. PCIA parameters were set as follows: background infusion rate was 0, self-controlled dosage was 0.3mg (5ml), locking time was 6min, and load was 1mg
Related Therapeutic Areas
Sponsors
Leads: The Fourth Affiliated Hospital of Zhejiang University School of Medicine