Effect of Postoperative Analgesia of Oliceridine Fumarate for Gastrointestinal Function Recovery in Patients Undergoing Lumbar Spine Surgery

Effect of Postoperative Analgesia of Oliceridine Fumarate for Gastrointestinal Function Recovery in Patients Undergoing Lumbar Spine Surgery:A Prospective, Multicenter, Double-blind,Randomized Controlled Study

Osemitidine fumarate is a novel G protein-biased ligand μ-opioid receptor agonist. Previous studies have confirmed its potent analgesic effects and safety: compared with morphine, it reduces respiratory depression and gastrointestinal dysfunction. This study aims to evaluate the effects of osemitidine on postoperative gastrointestinal function recovery and pain in patients undergoing lumbar spine surgery through a multicenter, double-blind, randomized controlled trial.

Study Overview

• Status: Not yet recruiting
• Conditions: Oliceridine Fumarate
• Intervention / Treatment: Drug: Oiceridine; Drug: Sufentanil

• Study Type: Interventional
• Enrollment (Estimated): 428
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hailong Dong; Phone Number: 13669226699; Email: hldong369@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oliceridine Group; Oliceridine Patient-Controlled Analgesia Pump After Lumbar Spine Surgery	Drug: Oiceridine; The postoperative PCA analgesic pump regimen is 0.5 mg/kg of oliceridine diluted with saline to 100 ml. The specific parameters are a loading dose: 0.03 mg/kg of Oxycodone diluted with saline to 3 ml, administered 20-30 minutes before the end of surgery. Background infusion rate: 1.5 ml/h, PCA dose: 1 ml, lockout interval: 10 minutes.
Active Comparator: Sufentanil Group; Sufentanil Patient-Controlled Analgesia Pump After Lumbar Spine Surgery	Drug: Sufentanil; The postoperative PCA analgesia pump configuration plan is 1.5 μg/kg sufentanil diluted with saline to 100 ml. The specific parameters are a loading dose: 0.1 μg/kg sufentanil diluted with saline to 3 ml, administered 20-30 minutes before the end of surgery. Background infusion rate: 1.5 ml/h, PCA dose: 1 ml, lockout time: 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients reaching the GI-3 composite endpoint within postoperative 24 hours	Proportion of patients reaching the GI-3 composite endpoint (tolerating solid food and passing gas/bowel movement) within postoperative 24 hours	postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients reaching the GI-3 composite endpoint within postoperative 48 hours	Proportion of patients reaching the GI-3 composite endpoint (tolerating solid food and passing gas/bowel movement) within postoperative 48 hours	postoperative 48 hours
GI-3	GI-3: Reach the later of the following two milestones: ① Time of solid food tolerance: No vomiting occurs within 4 hours after eating food that requires chewing ; ② Time of first flatus or first bowel movement (whichever comes first).	postoperative 48 hours
IFEED score	IFEED scores at postoperative 24 and 48 hours The I-FEED score is a novel outcome measure for POI, developed by expert consensus. It contains five elements (intake, response to nausea treatment, emesis, exam, and duration, each scored with 0, 1, or 3 points) and classifies patients into normal, postoperative gastrointestinal intolerance (POGI), and postoperative gastrointestinal dysfunction (POGD)(normal 0-2, POGI 3-5, POGD 6+ points)	postoperative 24 and 48 hours
Postoperative SPID	Summed Pain Intensity Difference at postoperative 24 and 48 hours	postoperative 24 and 48 hours
Opioid consumption	Opioid consumption at postoperative 24 and 48 hours	postoperative 24 and 48 hours
remedial analgesia	Times of remedial analgesia at postoperative 48 hours	postoperative 48 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative nausea and vomiting	Incidence of nausea and vomiting within 48 hours after surgery, proportion of patients requiring rescue antiemetics within 48 hours, and the amount of rescue antiemetics used within 48 hours	posoperative 48 hours

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 14, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: lumbar spine surgery; gastrointestinal function recovery
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Fentanyl; Sufentanil
• Other Study ID Numbers: KY20252506-F-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No