Efficacy and Safety of Oliceridine for Moderate to Severe Acute Pain After Orthopedic Surgery

NCT06320041 | Recruiting Phase 4

• 1 other identifier: KY-2024-028
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Pain score at rest 0-72 hours after surgery

  Patients' pain scores at rest were recorded from 0-72 hours after surgery.

  1 h (hour), 6 h,12 h,18 h,24 h,32 h,40 h,48 h,60 h,72 h (hours) after surgery

Secondary Outcomes (2)

• The total amount of opioid after operation.

  72 hours after surgery

• PCIA as a remedial analgesic press time

  during procedure (The moment to remove the PCIA pump.)

Study Arms (3)

low dose oxelidine group

EXPERIMENTAL

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

Drug: Low dose oxelidine group

high dose oxelidine group

EXPERIMENTAL

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

Drug: High dose oxelidine group

hydromorphone group

ACTIVE COMPARATOR

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

Drug: Hydromorphone group

Interventions

Low dose oxelidine group DRUG

Analgesic dose

low dose oxelidine group

High dose oxelidine group DRUG

Analgesic dose

high dose oxelidine group

Hydromorphone group DRUG

Analgesic dose

hydromorphone group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective orthopedic surgery under general anesthesia.
• The patient can communicate normally and has the correct expression of pain

You may not qualify if:

• Patients with advanced tumor
• Other acute and chronic pain conditions are present
• Severely obese (30 kg/m2)
• Pregnant or lactating women
• Allergy to opioids
• Sleep apnea syndrome
• Long-term opioid treatment
• Patients with mental and nervous system diseases, gastrointestinal obstruction, chronic obstructive pulmonary disease or pulmonary heart disease, cardiovascular disease
• Abnormal liver function during screening
• Abnormal renal function during screening

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Dongmei Ma

  The Fourth Affiliated Hospital of Zhejiang University School of Medicine

  STUDY CHAIR

Central Study Contacts

Dongmei Ma

CONTACT

+8615267358077; 8019111@zju.edu.cn

Li Li

CONTACT

+8618267858561; 65602423@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 20, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)