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Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery: A Multicenter, Randomized, Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Title: Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery: A Multicenter, Randomized, Controlled Trial The goal of this clinical trial is to evaluate the effectiveness and safety of tegileridine, a biased μ-opioid receptor agonist, for patient-controlled intravenous analgesia (PCIA) after abdominal surgery. The main question it aims to answer is: Is tegileridine superior to morphine in promoting the recovery of gastrointestinal function within 72 hours after abdominal surgery? Researchers will compare the experimental group (receiving Fumarate Tegileridine Injection) to the active control group (receiving Morphine Hydrochloride Injection). Both groups will also receive dexmedetomidine in their PCIA pumps. This comparison will determine if tegileridine is more effective for bowel recovery and has a better safety profile. Participants who are scheduled for elective abdominal surgery under general anesthesia will: 1. Be randomly assigned to receive either a tegileridine-based or a morphine-based pain relief pump after surgery. 2. Use the patient-controlled analgesia (PCA) pump for up to 72 hours postoperatively to manage their pain. 3. Be assessed for the time it takes for their bowel function to return (tolerating food and having gas or bowel movement). 4. Have their pain levels, overall recovery quality, sleep quality, and any side effects monitored during hospitalization. 5. Be followed up 30 days after surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Scheduled to undergo elective abdominal surgery under general anesthesia.

• Age ≥ 18 years.

• Body Mass Index (BMI) between 18 and 30 kg/m².

• American Society of Anesthesiologists (ASA) physical status classification of I to III.

• Requires postoperative analgesia and is capable of correctly using a patient-controlled intravenous analgesia (PCIA) pump.

• Understands the trial objectives and voluntarily participates, providing written informed consent.

Locations
Other Locations
China
Hunan Provincial Maternal and Child Health Care Hospital
RECRUITING
Changsha
Xiangya hospital of Central South Univesity
RECRUITING
Changsha
The Third Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Longyan Li, M.D., Ph.D.
lilongyan206@csu.edu.cn
+86-15273139192
Backup
Lirui Xian, M.B.
xianlirui123@163.com
+86-19198053454
Time Frame
Start Date: 2026-02-24
Estimated Completion Date: 2027-02-24
Participants
Target number of participants: 152
Treatments
Experimental: Tegileridine PCIA Group
Active_comparator: Morphine PCIA Group
Related Therapeutic Areas
Sponsors
Collaborators: Hunan Provincial Maternal and Child Health Care Hospital, Third Affiliated Hospital, Sun Yat-Sen University
Leads: Xiangya Hospital of Central South University

This content was sourced from clinicaltrials.gov