Comparison of the Analgesic Effect of Oliceridine Versus Morphine or Sufentanil for Postoperative Analgesia in Lumbar Surgeries: a Randomized Control Trial

NCT06990893 | Recruiting

• 1 other identifier: Sun Ling
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: This study aimed to compare the efficacy and safety of oliceridine versus morphine and sufentanil for postoperative analgesia following elective lumbar spine surgery. Methods: In this randomized, controlled trial, 90 patients scheduled for lumbar spine surgery were allocated in a 1:1:1 ratio to receive postoperative intravenous patient-controlled analgesia (PCIA) with either oliceridine (Group O，1.5mg oliceridine for loading dose， 0.5mg/kg oliceridine for PICA), morphine (Group M，4mg morphine for loading dose，1.5mg/kg morphine for PICA), or sufentanil (Group S，4ug sufentanil for loading dose，1.5ug/kg sufentanil for PICA). The primary outcome was the movement Visual Analogue Scale (VAS) score at 6 hours postoperatively. Secondary outcomes included resting and movement VAS scores, ramsay sation score at 0.5, 2, 6, 12, 24, and 48 hours postoperatively (excluding the motor VAS score at 6 hours postoperatively); number of PCIA demands and rescue analgesic requirements within 48 hours; hemodynamic parameters at 5, 10, 15, 30, and 60 minutes after administration of the initial loading dose. The incidence of adverse events within 48 hours postoperatively, such as nausea and vomiting, somnolence, respiratory depression, or pruritus.

Conditions

Sufentanil; Morphine; Validity; Safety; Oliceridine

Keywords

Sufentanil; Safety; Morphine; oliceridine

Outcome Measures

Primary Outcomes (1)

• the movement Visual Analogue Scale (VAS) score

  at 6 hours postoperatively

Study Arms (3)

The oliceridine group(O)

EXPERIMENTAL

A loading dose of 1.5mg of oliceridine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.01 mg.kg-1.h-1 orselidine was connected and diluted with normal saline to 100ml at a rate of 2ml per hour

Drug: Oliceridine

The morphine group(M)

EXPERIMENTAL

A loading dose of 4mg of morphine was intravenously injected. Ten minutes later, an intravenous analgesic pump was connected to 0.03mg.kg-1.h-1 morphine mixed with normal saline to 100ml at a rate of 2ml per hour

Drug: Morphine

The sufentanil group(S)

EXPERIMENTAL

A loading dose of 4ug of sufentanil was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03ug.kg-1.h-1 was connected. Sufentanil was mixed with normal saline to 100ml at a rate of 2ml per hour

Drug: Sufentanil

Interventions

Oliceridine DRUG

a loading dose of 1.5 mg of oliceridine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.01 mg.kg-1.h-1 oliceridine was connected with normal saline to 100 ml at a rate of 2 ml per hour

The oliceridine group(O)

Morphine DRUG

a loading dose of 4 mg of morphine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03 mg.kg-1.h-1 morphine was connected with normal saline to 100 ml at a rate of 2 ml per hour

The morphine group(M)

Sufentanil DRUG

A 4 ug loading dose of sufentanil was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03 ug.kg-1 h-1 was connected. sufentanil was mixed with normal saline to 100 ml at a rate of 2 ml per hour

The sufentanil group(S)

Eligibility Criteria

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

You may qualify if:

• Lumbar spine surgery with ASA grades I-III
• Aged 18-65 years
• Ethically, the patient voluntarily accepted this trial and signed the informed consent form

You may not qualify if:

• Severe respiratory and circulatory system diseases
• Nervous system disease
• Mental and psychological disorders
• Abnormal liver and kidney functions
• Participated in another drug clinical research within the past 30 days

Sponsors & Collaborators

• Anqing Municipal Hospital: lead

Study Sites (1)

Department of Anqing Hospital Anesthesiology

Anqing, Anhui, 246003, China

RECRUITING

MeSH Terms

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine; Morphine; Sufentanil

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; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Sun Ling Lu Sun Ling LU, Master's degree

CONTACT

15955565806; 348092640@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: May 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)