Actively Recruiting
A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetic Profile of TRD303 for Postoperative Analgesia After Abdominal Surgery in China.
Led by The Third Xiangya Hospital of Central South University · Updated on 2026-03-27
333
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multicenter, randomized, double-blind, placebo-positive, parallel-controlled, phase Ⅲ clinical trial of the efficacy, safety and pharmacokinetics of TRD303 solution for postoperative analgesia in patients undergoing abdominal surgery was conducted. The primary objective was to evaluate the efficacy of TRD303 solution for postoperative analgesia after abdominal surgery. The secondary objective was to evaluate the safety and pharmacokinetic profile of TRD303 solution for postoperative analgesia after abdominal surgery.
CONDITIONS
Official Title
A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetic Profile of TRD303 for Postoperative Analgesia After Abdominal Surgery in China.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study purpose and voluntarily agree to participate with signed consent
- Aged between 18 and 80 years, any gender
- Body mass index (BMI) between 18.0 and 30.0 kg/m2
- Minimum weight: 50.0 kg for men, 45.0 kg for women
- American Society of Anesthesiologists (ASA) grade I or II
- Scheduled for elective abdominal surgery under general anesthesia with a main incision length expected around 7�b12 cm
- Able to understand study procedures and communicate effectively with researchers
You will not qualify if you...
- Known allergy or contraindication to ropivacaine, amide local anesthetics, or study drugs
- Use of certain medications (e.g., class III antiarrhythmics, systemic glucocorticoids, anticonvulsants, sedatives, anxiolytics, antidepressants, CYP1A2 inhibitors, analgesics) within 5 half-lives before randomization
- Use of Chinese herbal medicines with analgesic effects within 7 days before randomization
- Planned use of hyperthermic perfusion, intraperitoneal chemotherapy, physical therapy, or other treatments affecting postoperative pain during the study
- Abdominal surgery within 1 year prior to consent
- Planned surgery at other sites during the study
- Other pain conditions that may affect pain evaluation
- History of congenital or idiopathic methemoglobinemia or glucose-6-phosphate dehydrogenase deficiency
- History or family history of malignant hyperthermia
- Poorly controlled blood pressure or significant abnormalities increasing perioperative risk
- Heart rate below 50 or above 100 beats/min, significant arrhythmias, or cardiac insufficiency
- Severe liver, kidney, cardiovascular, cerebrovascular, or metabolic diseases
- Advanced malignant tumors deemed unsuitable
- History of mental illness, dementia, migraine, or epilepsy affecting participation
- Skin infection, ulceration, or scar issues around the incision
- History of psychoactive or narcotic drug abuse, drug use, or heavy alcohol consumption prior to enrollment
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
2
Sichuan Provincial People's Hospital
Sichuan, China
Actively Recruiting
Research Team
W
wang, PhD
CONTACT
Y
yang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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