A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Abdominal Surgery
- Conditions
- Pain
- Registration Number
- NCT06890533
- Brief Summary
The primary objective is to evaluate the analgesic efficacy and safety of IV YZJ-4729 Tartrate Injection in patients with acute postoperative pain following abdominal surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 560
- Be able to understand the study purpose and cooperate with the study procedures of this trial, voluntarily provide written informed consent
- Body mass index (BMI) ≥18 kg/m2 and ≤28 kg/m2.
- ASA I - II
- Experiences a pain intensity rating of moderate to severe acute pain following abdominal surgery, with a pain intensity score of ≥4 on a Numeric Rating Scale (NRS) within 4 hours post-surgery
- Allergy to opioids and other medications that may be used during the trial.
- Nervous system disorders (e.g. epilepsy)
- Psychiatric disorders (e.g. depression)
- History of difficult airways
- Random blood glucose ≥11.1 mmol/L
- Uncontrolled blood pressure [e.g., hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg)，or hypotension(systolic blood pressure <90 mmHg)]
- Abnormal pulse oxygen saturation (SpO2 <90 %)
- Abnormal liver function or renal function
- Used agents that could affect the analgesic response
- Used agents that could affect drug metabolism
- Has previously participated in another YZJ-4729 clinical study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method the Sum of Pain Intensity Differences Over 24 Hours at rest 24 hours Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NRS), with higher numbers indicating a higher pain intensity, administered over 24 hours.
- Secondary Outcome Measures
Name Time Method The Time to first using rescue analgesics 24 hours The proportion of subjects using rescue analgesics 24 hours The number of times for rescue analgesics using 24 hours The cumulative dose used of rescue analgesics 24 hours the resting Sum of Pain Intensity Differences Over 6、12、18、12-24 Hours 24 hours the active Sum of Pain Intensity Differences Over 6、12、18、24、12-24 Hours 24 hours Participant satisfaction scores for analgesia treatment 24 hours Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 1 to 5, with 1 representing dissatisfied and 5 representing very satisfied.
Investigator satisfaction scores for analgesia treatment 24 hours Postoperative analgesia was evaluated by investigators. The scale ranges from 1 to 5, with 1 being dissatisfied and 5 being very satisfied.
Related Research Topics
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Trial Locations
- Locations (49)
The Second People's Hospital of Chengdu
🇨🇳Chengdu, China
The Third People's Hospital of Chengdu
🇨🇳Chengdu, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
Affiliated Zhongshan Hospital of Dalian University
🇨🇳Dalian, China
Deyang People's Hospital
🇨🇳Deyang, China
The Second People's Hospital of Yibin
🇨🇳Yibin, China
Zhangzhou Municipal of Fujian Province
🇨🇳Zhangzhou, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, China
Zhuzhou Central Hospital
🇨🇳Zhuzhou, China
Qingdao Central Hospital of Rehabilitation University
🇨🇳Qingdao, China
Cangzhou Central Hospital
🇨🇳Cangzhou, China
Cangzhou People's Hospital
🇨🇳Cangzhou, China
The First Hospital of Jilin University
🇨🇳Ch'ang-ch'un, China
Changde First People's Hospital
🇨🇳Changde, China
Changsha Hospital Affiliated to Hunan University
🇨🇳Changsha, China
The Fourth Hospital OF Changsha
🇨🇳Changsha, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, China
Dongguan People's Hospital
🇨🇳Dongguan, China
Ganzhou People's Hospital
🇨🇳Ganzhou, China
The First People's Hospital of Guangyuan
🇨🇳Guangyuan, China
Guangdong Province Traditional Chinese Medical Hospital
🇨🇳Guangzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, China
The First Affiliated Hospital of Jinan University
🇨🇳Guangzhou, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Ha'erbin, China
Haikou People's Hospital
🇨🇳Haikou, China
The Second People's Hospital of Hefei
🇨🇳Hefei, China
The First Affiliated Hospital of University of South China
🇨🇳Hengyang, China
Huzhou Central Hospital
🇨🇳Huzhou, China
The First Hospital of Jiaxing
🇨🇳Jiaxing, China
Liuzhou People's Hospital
🇨🇳Liuzhou, China
Liuzhou Workers' Hospital
🇨🇳Liuzhou, China
Luoyang Central Hospital
🇨🇳Luoyang, China
Ma'anshan People's Hospital
🇨🇳Ma'anshan, China
Mianyang Central Hospital
🇨🇳Mianyang, China
JiangXi Provincial People's Hospital
🇨🇳Nanchang, China
The Second Nanning People's Hospital
🇨🇳Nanning, China
The Second People's Hospital of Neijiang
🇨🇳Neijiang, China
Ningbo Medical Center Lihuili Hospital
🇨🇳Ningbo, China
Shanghai First Maternity and Infant Hospital
🇨🇳Shanghai, China
Shanghai Fourth People's Hospital
🇨🇳Shanghai, China
Taizhou People's Hospital
🇨🇳Taizhou, China
The Second Hospital of Tianjin Medical University
🇨🇳Tianjin, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, China
Wuhan Third Hospital
🇨🇳Wuhan, China
Affiliated Hospital of Jiangnan University
🇨🇳Wuxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, China
Zhongshan Hospital Xiamen University
🇨🇳Xiamen, China