Tegileridine vs Sufentanil for Postoperative Pain Management and Gastrointestinal Recovery After Major Laparoscopic Abdominal Surgery

NCT07637968 | Not Yet Recruiting Phase 4

• 1 other identifier: IIT-CRU-FAMB-2026HS100
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a single-center, randomized, triple-blind clinical trial designed to compare tegileridine and sufentanil for postoperative analgesia and gastrointestinal tolerability in patients undergoing major laparoscopic abdominal surgery. Participants will be randomly assigned to receive either tegileridine or sufentanil for postoperative patient-controlled intravenous analgesia according to the study protocol. The purpose of this study is to determine whether tegileridine can provide better gastrointestinal tolerability while maintaining non-inferior postoperative pain control compared with sufentanil in this patient population.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve of Resting Pain Intensity Within 24 Hours After Admission to the PACU

  The cumulative resting pain score within 24 hours after admission to the post-anesthesia care unit (PACU) will be represented by the area under the curve of the numeric rating scale (NRS) scores from 0 to 24 hours. Resting pain intensity will be assessed using an 11-point NRS, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. NRS scores will be measured at 0, 6, 12, 18, and 24 hours after admission to the PACU.

  From 0 to 24 hours after admission to the PACU

Secondary Outcomes (8)

• Resting and Movement Pain Intensity

  At 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU

• PCIA Demand and Effective Press Counts

  Within 48 hours after admission to the PACU.

• Use of Rescue Analgesia

  Within 72 hours after admission to the PACU

• Incidence and Severity of PONV

  Within 72 hours after admission to the PACU

• Time to First Flatus

  From admission to the PACU until first passage of flatus, assessed up to 1 week.

Other Outcomes (2)

• Changes in Inflammatory Biomarkers

  Before surgery and at predefined time points within 72 hours after admission to the PACU

• Changes in I-FABP

  Before surgery and at predefined time points within 72 hours after admission to the PACU

Study Arms (2)

Tegileridine Group

EXPERIMENTAL

Participants in this group will receive postoperative patient-controlled intravenous analgesia containing tegileridine 5 mg and palonosetron 0.5 mg diluted with normal saline to a total volume of 100 mL. The analgesia pump will be administered intravenously at a background infusion rate of 1.5 mL/hour, with a bolus dose of 1.5 mL and a lockout interval of 15 minutes.

Drug: Tegileridine; Drug: Palonosetron

Sufentanil Group

ACTIVE COMPARATOR

Participants in this group will receive postoperative patient-controlled intravenous analgesia containing sufentanil 100 micrograms and palonosetron 0.5 mg diluted with normal saline to a total volume of 100 mL. The analgesia pump will be administered intravenously at a background infusion rate of 1.5 mL/hour, with a bolus dose of 1.5 mL and a lockout interval of 15 minutes.

Drug: Sufentanil; Drug: Palonosetron

Interventions

Tegileridine DRUG

Tegileridine 5 mg will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.

Tegileridine Group

Sufentanil DRUG

Sufentanil 100 micrograms will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.

Sufentanil Group

Palonosetron DRUG

Palonosetron 0.5 mg will be included in the postoperative patient-controlled intravenous analgesia solution in both study groups for antiemetic prophylaxis.

Sufentanil Group; Tegileridine Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years.
• Elective major abdominal surgery as defined above.
• Body mass index (BMI) 18-30 kg/m².
• American Society of Anesthesiologists (ASA) physical status I to III.
• Written informed consent.

You may not qualify if:

• Known hypersensitivity to opioids or any component of the study medications.
• Clinically significant hypoxemia, such as oxygen saturation less than 90 percentage, or a history of severe asthma.
• Known or suspected gastrointestinal obstruction, including paralytic ileus.
• Pregnancy or breastfeeding.
• Severe hepatic impairment (Child-Pugh class C).
• Severe heart failure (NYHA class III-IV) or unstable arrhythmia.
• Neurological or psychiatric disorders that may interfere with pain or sedation assessment (e.g., epilepsy, impaired consciousness, uncontrolled psychiatric illness).
• History of chronic pain or long-term use of analgesics/analgesic products.
• Current use of sedative-hypnotic medications.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sufentanil; Palonosetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Jihong Jiang, MD

CONTACT

86-13482002227; jiangjihong@outlook.com

Jie Xiao

CONTACT

86-18353689295; XiaoJie20220747@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, and outcomes assessors will be blinded to group allocation. Study drugs will be prepared and labeled by personnel not involved in postoperative care or outcome assessment to maintain blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Anesthesiology

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the tegileridine group or the sufentanil group for postoperative patient-controlled intravenous analgesia.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share