Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06409689

Enhanced Postoperative Pain Relief and Faster Recovery With Oliceridine Compared to Morphine Using G-Protein Biased μ-Opioid Agonists

Led by Tongji Hospital · Updated on 2025-01-03

80

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients undergoing upper abdominal laparoscopic surgery to find the best dose of oliceridine, a pain relief drug, that quickly reduces postoperative pain while limiting side effects. This study also looks at how oliceridine may speed up recovery by evaluating lung complications, digestive function, nausea, vomiting, mental health, and cognitive function. Additionally, the study explores the molecular effects of oliceridine using microbiomics and metabolomics to better understand how it helps recovery, providing new clinical insights. Eighty patients are divided into four groups receiving different doses of oliceridine (low, medium, high) or morphine for pain control after surgery. All groups get an initial dose followed by patient-controlled analgesia (PCA) with specific dosing schedules and limits. The lockout interval between doses is 6 minutes, and supplemental doses are allowed hourly up to a set daily maximum depending on the group. This approach helps compare the effects of varying analgesic regimens. Participants are monitored for pain at 6, 24, and 48 hours after surgery using a pain rating scale. Other assessments include vital signs, nausea and vomiting scores, lung complication checks, digestive function scoring, and mental and cognitive tests before and after surgery. Fecal samples are collected before and 48 hours after surgery for molecular studies. The study uses these clinical and molecular results to evaluate the safety, effectiveness, and recovery benefits of oliceridine compared to morphine.

CONDITIONS

Official Title

Oliceridine-Enhanced Analgesia and Recovery: A G-Protein Biased μ-Opioid Study

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA physical status grades 1 or 2
  • Age over 18 years and under 70 years
  • Scheduled for laparoscopic upper abdominal surgery under general anesthesia with operation time no more than 4 hours
  • Willing to receive postoperative controlled intravenous analgesia
  • Able to understand and cooperate with study procedures
  • Able to provide and sign written informed consent before study screening
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) over 30 kg/m2 or under 19 kg/m2
  • Preoperative opioid use or presence of acute or chronic pain or increased sensitivity to pain
  • History of coronary atherosclerotic heart disease, significant ischemic heart disease, severe angina, heart failure, valvular or other heart diseases
  • Severe liver or kidney insufficiency
  • History of mental illness or alcoholism
  • History of alcohol or drug abuse
  • Conditions with increased cranial pressure, intraocular pressure, or glaucoma
  • Poorly controlled or untreated hypertension before surgery
  • Presence of preeclampsia or eclampsia
  • Untreated or undertreated hyperthyroidism
  • Presence of autoimmune disease
  • Inability to use the numerical rating pain scale
  • History of chronic cough
  • Expected surgery duration over 4 hours
  • Participation in other clinical trials within the last 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tongji Hospital

Wuhan, Hubei, China

Actively Recruiting

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Research Team

H

Hui Xu

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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