the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery
NCT Number: NCT06530563
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Acute Pain|Opioid Analgesic Adverse Reaction
Interventions: DRUG: Oliceridine Injection [Olinvyk]|DRUG: Sufentanil Citrate
Sponsor: Xiangya Hospital of Central South University
Collaborators: Wu Jieping Medical Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 606
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12-31
Locations: Xiangya Hospital of Central South University, Changsha, Hunan, 410000, China

Summary:
The goal of this clinical trial is to learn if Oliceridine fumarate injection works to treat acute pain after abdominal surgery. It will also learn about the safety of Oliceridine fumarate injection. The main questions it aims to answer are:

1. Does Oliceridine fumarate injection works to treat acute pain after abdominal surgery?
2. Does Oliceridine fumarate injection lead to less adverse effect?

Researchers will compare Oliceridine fumarate injection to a positive-drug (Sufentanil Citrate) to see if Oliceridine fumarate injection not inferior to sufentanil in the efficacy and safety for acute pain after abdominal surgery.

Participants will:

1. Receive patient controlled analgesia treat using Oliceridine or sufentanil after surgery
2. Be followed up every 6 hours until 48 hours after surgery or before discharge

Primary Outcome Measures: Area under the pain intensity time curve (AUC0-48, time in hours) in resting and moving states as assessed by numerical rating scale(NRS) at 48 hours, Numerical rating scale(NRS), values from 0 to 10, 0 means "no pain", 10 means "the most intense pain", the higher score means a worse outcome; Area under the pain intensity time curve (AUC0-48), time in hours., 48 hours
Secondary Outcome Measures: Area under the pain intensity time curve (AUC) in resting and moving states as assessed by NRS at 12 and 24 hours, Area under the pain intensity time curve (AUC) in resting and moving states as assessed by NRS at 12 and 24 hours, 12 or 24 hours|total dose of rescue analgesics within 48 hours, rescue analgesics include flurbiprofen axetil injection, parecoxib sodium and ketorolac tromethamine, reported in mg., 48 hours or the liquid of pump has run out before 48 hours.|proportion of patients used rescue analgesics, proportion of patients used rescue analgesics, 48 hours or when the liquid of pump has run out before 48 hours.|Incidence of respiratory depression, Incidence of respiratory depression (i.e., respiratory rate ≤8 breaths/minute or oxygen saturation (SpO2)\<90%), 48 hours|The occurrence of nausea and vomiting, The proportion of patients with nausea and vomiting within 48 hours and the proportion of patients using antiemetic drugs. Antiemetic drugs (i.e., ondansetron or tropisetron) report in mg., 48 hours|Condition of sedation, Condition of sedation is assessed by observer's assessment alert/Sedation(OAA/S), value from 0 to 5, grade 0 means deep sedation, grade 5 means fully awake., 48 hours|the occurrence of adverse events, the occurrence of adverse events, 1 month|Satisfaction scores within 48 h of the participants and researchers, Satisfaction scores grade from 1 to 5. 5 means very satisfied, 4 means satisfied, 3 means general satisfied, 2 means not satisfied, 1 means very dissatisfied., 48hours
Other Outcome Measures: the analgesic effect and adverse reactions of Oliceridine in preoperative and postoperative hypertensive patients taking angiotensin-converting enzyme inhibitor/angiotensin receptor blocker(ACEI/ARB) drugs, the analgesic effect include the area under the pain intensity time curve (AUC, time in hours) in resting and moving states as assessed by numerical rating scale(NRS) at 12, 24 and 48 hours, the proportion of using rescue analgesics. The adverse reactions include the proportion of patients with nausea and vomiting within 48 hours and the proportion of patients using antiemetic drugs, the incidence of respiratory depression and the condition of sedation assessed by observer's assessment alert/Sedation(OAA/S)., 1 month