A Phase 4 interventional study of Tegileridine and Oliceridine in Gynecologic Laparoscopic Surgery and Postoperative Gastrointestinal Dysfunction, sponsored by Hainan Medical College. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Hainan Medical College · Phase 4, Interventional, and Treatment
This randomized controlled clinical trial aims to evaluate the effects of different opioid analgesics on gastrointestinal recovery after gynecologic laparoscopic surgery.
Opioid medications are commonly used to manage pain after surgery, but they may cause nausea, vomiting, constipation, and delayed recovery of bowel function. Biased μ-opioid receptor agonists, such as tegileridine and oliceridine, may provide effective pain relief with fewer gastrointestinal side effects than conventional opioids.
The main question is whether biased opioid receptor agonists can shorten the time to postoperative gastrointestinal recovery compared with sufentanil, a conventional opioid analgesic.
The study plans to enroll 212 adults undergoing elective gynecologic laparoscopic surgery. Participants will be randomly assigned to one of four groups:
After surgery, participants will receive the assigned medication through a patient-controlled intravenous analgesia (PCIA) pump.
The primary outcome is time to gastrointestinal recovery (GI-2), defined as the time from the end of surgery until both the first bowel movement (defecation) and tolerance of solid food have occurred. The later of these two events determines the GI-2 recovery time.
Researchers will also assess the time to first passage of flatus, postoperative nausea and vomiting, gastrointestinal function scores, pain intensity, gastrointestinal ultrasound findings, analgesic requirements, and medication-related adverse events.
The findings may help determine whether biased opioid receptor agonists offer advantages over conventional opioid analgesics in supporting gastrointestinal recovery while maintaining adequate postoperative pain control.
Postoperative gastrointestinal dysfunction is a common concern following gynecologic laparoscopic surgery. Although opioid analgesics are widely used for postoperative pain management, their effects on gastrointestinal motility may contribute to delayed bowel function recovery, postoperative nausea and vomiting, and patient discomfort.
Biased μ-opioid receptor agonists have been developed to provide analgesia through preferential activation of specific opioid receptor signaling pathways. Tegileridine and oliceridine are of clinical interest because of their potential to provide effective postoperative analgesia while reducing certain opioid-associated adverse effects. However, their effects on gastrointestinal recovery following gynecologic laparoscopic surgery remain to be established.
This study is a prospective, randomized, controlled, single-center clinical trial conducted at the Second Affiliated Hospital of Hainan Medical University. A total of 212 adult patients undergoing elective gynecologic laparoscopic surgery are planned to be enrolled.
Participants will be randomly allocated to four parallel treatment groups receiving postoperative patient-controlled intravenous analgesia (PCIA) with one of the following regimens:
The primary outcome is time to gastrointestinal recovery (GI-2), defined as the time from the end of surgery until both the first bowel movement (defecation) and tolerance of solid food have occurred. GI-2 recovery time is determined by the later of these two events and is measured in hours.
Secondary outcomes include time to first passage of flatus, time to first bowel movement, postoperative gastrointestinal function assessed using the I-FEED score, postoperative nausea and vomiting, postoperative pain intensity assessed using the Visual Analog Scale (VAS), patient-controlled analgesia use, rescue analgesia requirements, and medication-related adverse events.
Gastrointestinal ultrasound examinations will be performed to assess postoperative gastrointestinal function, including gastric antral cross-sectional area and small bowel peristaltic activity. These measurements are intended to provide additional objective information about gastrointestinal recovery.
The study will compare postoperative gastrointestinal recovery, analgesic effectiveness, and safety outcomes across the four treatment groups. The findings may provide clinical evidence to inform the selection of postoperative opioid analgesic regimens for patients undergoing gynecologic laparoscopic surgery.
Hainan Medical College is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive postoperative patient-controlled intravenous analgesia (PCIA) with tegileridine at a prescribed dose of 0.07 mg/kg.
Drug: Tegileridine
Participants receive postoperative patient-controlled intravenous analgesia (PCIA) with tegileridine at a prescribed dose of 0.11 mg/kg.
Drug: Tegileridine
Participants receive postoperative patient-controlled intravenous analgesia (PCIA) with oliceridine at a prescribed dose of 0.36 mg/kg.
Drug: Oliceridine
Participants receive postoperative patient-controlled intravenous analgesia (PCIA) with sufentanil at a prescribed dose of 2.0 micrograms/kg.
Drug: Sufentanil
Tegileridine is administered by patient-controlled intravenous analgesia (PCIA) after gynecologic laparoscopic surgery. The prescribed dose is 0.07 mg/kg in the low-dose group and 0.11 mg/kg in the high-dose group. Participants receive only their assigned dose regimen.
Oliceridine is administered by patient-controlled intravenous analgesia (PCIA) after gynecologic laparoscopic surgery at a prescribed dose of 0.36 mg/kg.
Sufentanil is administered by patient-controlled intravenous analgesia (PCIA) after gynecologic laparoscopic surgery at a prescribed dose of 2.0 micrograms/kg. This group serves as the active comparator.
Time to Gastrointestinal Recovery (GI-2)
GI-2 is defined as the time from the end of surgery until both the first bowel movement (defecation) and tolerance of solid food have occurred. The later of these two events determines the GI-2 recovery time, measured in hours. Participants who do not achieve GI-2 within 7 days will be recorded as not having reached the endpoint during the follow-up period.
Time frame: From the end of surgery up to 7 days postoperatively.
Time to First Passage of Flatus
Time from the end of surgery to the first passage of flatus, measured in hours. A shorter time indicates earlier recovery of postoperative bowel function.
Time frame: From the end of surgery up to 7 days postoperatively.
Postoperative Gastrointestinal Function (I-FEED Score)
Gastrointestinal function assessed using the I-FEED score at each scheduled postoperative assessment. The protocol describes a score ranging from 0 to 10, with higher scores indicating worse gastrointestinal function.
Time frame: At 6, 24, and 48 hours postoperatively.
Postoperative Pain Intensity (VAS Score)
Postoperative pain intensity assessed using a 0-to-10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores are recorded at each scheduled assessment.
Time frame: At 6, 24, and 48 hours postoperatively.
Incidence of Postoperative Nausea and Vomiting
Percentage of participants experiencing at least one episode of nausea or vomiting within 48 hours after surgery.
Time frame: Within 48 hours postoperatively.
Small Bowel Peristaltic Frequency
Frequency of small bowel peristaltic movements assessed by ultrasonography, expressed as contractions per minute.
Time frame: At 6, 24, and 48 hours postoperatively.
Incidence of Opioid-Related Adverse Reactions
Percentage of participants experiencing at least one opioid-related adverse reaction, including dizziness, somnolence, respiratory depression, pruritus, abdominal distension, or constipation, within 48 hours after surgery.
Time frame: Within 48 hours postoperatively.
Number of Patient-Controlled Analgesia Button Presses
Total number of patient-initiated button presses recorded by the patient-controlled intravenous analgesia pump during the first 48 hours after surgery.
Time frame: Within 48 hours postoperatively.
Number of Rescue Analgesia Administrations
Total number of rescue analgesic administrations received by each participant within 48 hours after surgery.
Time frame: Within 48 hours postoperatively.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Tegileridine · Oliceridine · Sufentanil
Hainan Medical College