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NCT Number: NCT07307495

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

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.

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Key information

Conditions

Oliceridine Fumarate

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sufentanil

Drug

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.

Oiceridine

Drug

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.

Primary outcomes

  1. Proportion of patients reaching the GI-3 composite endpoint within postoperative 24 hours

    Time frame: postoperative 24 hours

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

Secondary outcomes

  1. Proportion of patients reaching the GI-3 composite endpoint within postoperative 48 hours

    Time frame: postoperative 48 hours

    Proportion of patients reaching the GI-3 composite endpoint (tolerating solid food and passing gas/bowel movement) within postoperative 48 hours

  2. GI-3

    Time frame: postoperative 48 hours

    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).

  3. IFEED score

    Time frame: postoperative 24 and 48 hours

    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)

  4. Postoperative SPID

    Time frame: postoperative 24 and 48 hours

    Summed Pain Intensity Difference at postoperative 24 and 48 hours

  5. Opioid consumption

    Time frame: postoperative 24 and 48 hours

    Opioid consumption at postoperative 24 and 48 hours

  6. remedial analgesia

    Time frame: postoperative 48 hours

    Times of remedial analgesia at postoperative 48 hours

Other outcomes

  1. Postoperative nausea and vomiting

    Time frame: posoperative 48 hours

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Hailong Dong

CONTACT

[email protected]

13669226699

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.