Postoperative analgesia with osemitidine fumarate for faster gut function after lumbar spine surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, double-blind, randomized trial compares osemitidine fumarate to another analgesic in adults undergoing lumbar spine surgery. The aim is to see if the new drug improves postoperative gastrointestinal function while controlling pain. Participants are adults 18-75 without major comorbidities, and receive postoperative patient-controlled analgesia. Outcomes include GI recovery time and pain scores, with safety monitoring for adverse effects. The study is conducted at Xi’an and involves leading researchers from Xijing Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age between 18 and 75 years old;
* Patients undergoing lumbar surgery under general anesthesia (within 3 segments) and expected to receive postoperative patient-controlled analgesia;
* ASA classification I-III;
* BMI between 18 and 30 kg/m²;
* Informed consent obtained from the patient.

Exclusion Criteria:

* Use of any painkillers within 3 days before surgery; or long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), defined as: within 3 months before surgery, use of NSAIDs daily for more than 2 consecutive weeks;
* Presence of intestinal obstruction or suspicious symptoms: nausea and vomiting, abdominal bloating and pain, cessation of gas or bowel movements within the past two weeks, imaging suggesting intestinal dilation, or large amounts of air-fluid levels;
* Patients with severe liver dysfunction (based on Child-Pugh classification, grade C);
* History of or planned gastrointestinal surgery;
* Patients allergic to the study drug;
* Pregnant or breastfeeding patients;
* QTcF abnormalities, males \>450 ms, females \>470 ms;
* Participation in other drug trials within the past 30 days;
* Long-term use of opioids (defined as: within 12 months before surgery, use for more than 1 month, more than 3 days per week, with daily doses exceeding 15 mg morphine equivalent);
* Pre-existing neurological or psychiatric disorders: such as epilepsy, depression, schizophrenia, etc.;
* Patients deemed unsuitable for this study by the investigator.

Where it's running

• the First Affiliated Hospital of Air Force Military Medical University
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Hailong Dong
• Email: hldong369@hotmail.com
• Phone: 13669226699

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.