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

NCT06409689 | Recruiting

• 1 other identifier: S058
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Identifying the lowest effective opioid dose that achieves rapid pain relief while minimizing side effects is a principal objective in postoperative multimodal analgesia strategies. This study aims to determine the optimal analgesic regimen and dosage by assessing the clinical efficacy of oliceridine for postoperative pain management. It also evaluates oliceridine's contribution to accelerated postoperative recovery, examining aspects such as postoperative pulmonary complications, gastrointestinal function, nausea and vomiting, cognitive function, and emotional distress. Furthermore, the study integrates microbiomics and metabolomics to investigate the underlying molecular mechanisms by which oliceridine promotes rapid postoperative recovery. This research will broaden the clinical data and potential applications of oliceridine, addressing gaps in the field and enhancing practical knowledge. Moreover, this is the first time a clinical study combining multiple omics approaches will provide a comprehensive theoretical foundation for its clinical benefits.

Conditions

Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• postoperative pain score

  The NRS Numerical Pain Evaluation Scale assessed postoperative pain status: no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10).

  6 hour, 24hour, and 48 hour after surgery

Secondary Outcomes (4)

• Postoperative nausea and vomiting

  6 hour, 24 hour, and 48 hour after surgery

• Postoperative pulmonary complications

  24 hour,72 hour after surgery

• Postoperative cognitive function

  Before surgery, 3 days after surgery

• Flora abundance

  One day before surgery and 48 hours after surgery

Study Arms (4)

Oliceridine fumarate low dose group

EXPERIMENTAL

The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.1 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 27mg. The duration of PCA analgesia was 48 hours.

Drug: Oliceridine fumarate low dose

Oliceridine fumarate medium dose group

EXPERIMENTAL

The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.35mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 27mg. The duration of PCA analgesia was 48 hours.

Drug: Oliceridine fumarate moderate dose

Oliceridine fumarate high dose group

EXPERIMENTAL

The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.5 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 27mg. The duration of PCA analgesia was 48 hours.

Drug: Oliceridine fumarate high dose

Morphine group

EXPERIMENTAL

The first loading dose of morphine was 4 mg in all patients after operation. The PCA dose of the patients was 1 mg, and the locking interval was 6 min. A supplemental dose of 2 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 60 mg. The duration of PCA analgesia was 48 hours.

Drug: morphine

Interventions

Oliceridine fumarate low dose DRUG

The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.1 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose

Oliceridine fumarate low dose group

Oliceridine fumarate high dose DRUG

The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.5 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose

Oliceridine fumarate high dose group

Oliceridine fumarate moderate dose DRUG

The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.35 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose

Oliceridine fumarate medium dose group

morphine DRUG

The first loading dose of morphine was 4 mg in all patients after operation. The PCA dose of the patients was 1 mg, and the locking interval was 6 min. A supplemental dose of 2 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 60 mg.

Morphine group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA grades 1-2
• Age \> 18 years and \< 70 years
• Laparoscopic upper abdominal surgery under general anesthesia is planned, and the operation time is not more than 4 hours
• Voluntarily receive postoperative controlled intravenous analgesia
• Subjects understand and can cooperate with this study
• Subjects can provide and sign written informed consent prior to conducting investigation-related screening procedures

You may not qualify if:

• BMI\>30 kg/m2 or \< 19 kg/m2
• Patients with preoperative use of opioids, acute and chronic pain or hyperalgesia
• Patients with coronary atherosclerotic heart disease, significant ischemic heart disease, severe angina, heart failure, valvular disease or other heart disease
• More severe hepatic and renal insufficiency
• A history of mental illness or alcoholism
• A history of alcohol or drug abuse
• Combined with cranial pressure, intraocular pressure or glaucoma
• Poorly controlled or untreated hypertension before surgery
• Preeclampsia or eclampsia
• Untreated and undertreated hyperthyroidism
• Combined with autoimmune disease
• Unable to use the numerical rating scale
• History of chronic cough
• Surgery is expected to take more than 4 hours Patients enrolled in other clinical trials within 3 months

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Hui Xu

CONTACT

+8613971001596; huixu@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 3, 2025

Record last verified: 2025-01

Locations

CN (1)