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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAnqing Municipal Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Severe respiratory and circulatory system diseases

Nervous system disease

Mental and psychological disorders

Abnormal liver and kidney functions

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

  • 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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: The oliceridine group(O)Experimental treatment 1 intervention
Group B: The morphine group(M)Experimental treatment 1 intervention
Group C: The sufentanil group(S)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

the movement Visual Analogue Scale (VAS) score

Time frame
at 6 hours postoperatively

Secondary outcomes

Other outcomes

Sponsors and contacts

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