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

Not Applicable

Recruiting

• Conditions: Sufentanil; Morphine; Validity; Safety; Oliceridine
• Interventions: Drug: Sufentanil; Drug: Oliceridine; Drug: Morphine

• Registration Number: NCT06990893
• Lead Sponsor: Anqing Municipal Hospital

Brief Summary

Objective: To compare the application of oxelidine in postoperative analgesia after orthopedic lumbar spine surgery with morphine or sufentanil, and to explore the efficacy and safety of postoperative analgesia.

Method: Researchers included 90 patients with American Society of Anesthesiologists (ASA) physical conditions I and III, aged 18 to 65 years, who were scheduled to undergo orthopedic lumbar general anesthesia surgery at an appropriate time. The patients were randomly divided into 3 groups, with 30 cases in each group: The oxeridine group (Group A), where a loading dose of 1.5mg of oxeridine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.01mg/kg-1.h-1 was connected. Oxeridine was mixed with normal saline to 100ml at a rate of 2ml/h. Morphine group (Group M), a loading dose of 4mg of morphine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03mg.kg-1.h-1 morphine was connected with normal saline to 100ml at a rate of 2ml/h. Sufentanil group (Group S), a 4u loading dose of sufentanil was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03ug.kg-1.h-1 was connected. Sufentanil was combined with normal saline to 100ml at a rate of 2ml/h.The resting and exercise VAS pain scores of the three groups of patients at 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours and 48 hours after the operation and adverse reactions within 48 hours were recorded.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-11-11
• Study First Submitted: 2025-05-18
• Study First Submitted QC: 2025-05-18
• Last Update Submitted: 2025-05-18
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The sufentanil group(S)	Sufentanil	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
The oliceridine group(A)	Oliceridine	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
The morphine group(M)	Morphine	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

Primary Outcome Measures

Name	Time	Method
The VAS pain scores at rest and during exercise of the three groups of patients after the operation	at 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours and 48 hours after the operation

Trial Locations

Locations (1)

Department of Anqing Hospital Anesthesiology; 🇨🇳 Anqing, Anhui, China