Not Yet RecruitingNot Applicable

Effect of Preventive Analgesia with Oxycodone and Parecoxib Sodium on the Chronification of Acute Post-operative Pain

1,316 participantsStarted 2025-01-01

Plain-language summary

The goal of this clinical trial is to learn if the administration of oxycodone for preventive analgesia works to reduce the chronification of acute postoperative pain in adult participants undergoing major abdominal surgery. The main question it aims to answer is: • Does administration of oxycodone before surgical incision reduce the occurrence of chronic pain or relieve the chronic pain symptoms 3 months after the operation? Researchers will compare oxycodone + parecoxib sodium to placebo + parecoxib sodium combinations to see if oxycodone works to reduce the chronification of acute postoperative pain. Participants will: * Take oxycodone + parecoxib sodium or placebo + parecoxib sodium combinations before the surgical incision * Cooperate with the follow-up staffs and complete some checkups or tests within 3 months after the operation.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ASA I\~III； * BMI ranging from 18 to 28 kg/m²； * For elective laparoscopic-assisted major abdominal surgery under general anesthesia; * Estimated surgical duration (from incision to the last suture of the skin) was at least 2 hours. Exclusion Criteria: * Pregnant or lactating patients; * Patients diagnosed with septic shock or multiple organ failure within 14 days; * Patients with preoperative severe electrolyte disorders; * Patients with stroke, transient ischemic attack, or other similar events within the past 3 months * Patients with unstable angina, myocardial infarction within the past 3 months; or presence of untreated arrhythmia or arrhythmia not well-controlled with treatment; * Patients with diabetes, uncontrolled blood glucose levels, or diabetes complications such as diabetic ketoacidosis, hyperosmolar coma, diabetes-related infections, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic peripheral neuropathy, diabetic foot, etc. before the surgery; * Patients with severe liver dysfunction (Child-Pugh score \> 6), renal dysfunction (GFR \< 90 ml/(min•1.73m²)); * Exploratory surgeries, day surgeries, or surgeries that only involve opening and closing the abdomen; * Blood pressure ≥180/110 mmHg at rest (≥Grade 3 hypertension according to the 2020 ISH Hypertension Guidelines); or systolic blood pressure \<90 mmHg or mean blood pressure \<65 mmHg; * Patients participated in other drug trials within the past 3 months; * Patients…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visceral pain scores in the surgical area at 90 days postoperatively.

Timeframe: 90 days after the surgery

The incidence of moderate to severe visceral pain at 90 days postoperatively.

Timeframe: 90 days after the surgery

Trial details

NCT IDNCT06721988

SponsorAilin Luo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Luo Ailin

86-027-83665480 alluo@hust.edu.cn

View on ClinicalTrials.gov More Oxycodone trials