Acute Pain, Opioid Analgesic Adverse Reaction
Conditions
Keywords
Oliceridine, acute pain after surgery, abdominal surgery
Brief 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
Detailed description
Traditional opioid, such as morphine, sufentanil , is an important drug treatment of postoperative period of acute pain, but their use is often limited because of significant side effects, such as respiratory depression, postoperative nausea and vomiting and sedation. If a drug is effective treatment of postoperative pain and avoid these adverse reactions, it will shorten the postoperative recovery time of patients, increase patients' satisfaction, and reduce hospitalization costs. Basic research shows that traditional opioids mainly bind to μ-opioid receptors and activate G protein signal transduction to exert analgesic effect. In addition, they stimulate the recruitment of β-arrestin, leading to respiratory depression, nausea and vomiting and other side effects. Oliceridine is a newly μ-opioid receptor agonist, which mainly activates the G protein signaling pathway to exert analgesic effect, but has a weak recruitment effect on β-arrestin and thus reduces the incidence of adverse reactions. However, due to its recent introduction to the market, there is still a lack of large-scale clinical studies on the application of Oliceridine in the population. So this topic to discuss the analgesic efficacy and adverse reactions of Oliceridine in patients with acute pain after abdominal surgery. Our study hypothesized that Oliceridine would have comparable analgesic efficacy and a lower incidence of associated side effects than sufentanil.
Interventions
DRUGOliceridine Injection [Olinvyk]
Oliceridine fumarate injection, specifications: 1mg/1mL, 2mg/2 mL, 10mg/10 mL; Stored in the dark, 15-30 ℃, not frozen; Jiangsu Nhwa pharmaceutical co., LTD. Production. Dexmedetomidine, specifications: 200ug/2ml; Ondansetron, specifications: 8mg/4ml.
Sufentanil Citrate injection, specification: 50 ug/ml, 1 ml; Avoid light seal; Yichang humanwell pharmaceutical co., LTD. Dexmedetomidine, specifications: 200ug/2ml; Ondansetron, specifications: 8mg/4ml.
Sponsors
Wu Jieping Medical Foundation
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1.Preoperative inclusion criteria 1. aged ≥18 years and ≤75 years at screening; 2. Plan to undergo open or laparoscopic abdominal surgery, and the estimated operative time more than 2 hours. 3. able to understand and comply with research procedures and requirements, and can provide a written informed consent. 2.postoperative inclusion criteria: 1. patients who required open or laparoscopic surgery; 2. According to the investigator's judgment, the patient had recovered sufficiently from the intraoperative anesthesia protocol to accurately complete the protocol-specified questionnaire;
Exclusion criteria
1.preoperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the pain intensity time curve (AUC0-48, time in hours) in resting and moving states as assessed by numerical rating scale(NRS) during postoperative 48 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the pain intensity time curve (AUC) in resting and moving states as assessed by NRS during postoperative 12 hours and 24 hours. | 12 or 24 hours | Area under the pain intensity time curve (AUC) in resting and moving states as assessed by NRS during postoperative 12 and 24 hours |
| total dose of rescue analgesics within 48 hours | 48 hours or the liquid of pump has run out before 48 hours. | rescue analgesics include flurbiprofen axetil injection, parecoxib sodium and ketorolac tromethamine, reported in mg. |
| proportion of patients used rescue analgesics | 48 hours or when the liquid of pump has run out before 48 hours. | proportion of patients used rescue analgesics |
| Incidence of respiratory depression | 48 hours | Incidence of respiratory depression (i.e., respiratory rate ≤8 breaths/minute or oxygen saturation (SpO2)\<90%) |
| The occurrence of nausea and vomiting | 48 hours | 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. |
| the occurrence of adverse events | 1 month | the occurrence of adverse events |
| Satisfaction scores within 48 h of the participants and researchers | 48 hours | 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. |
| the use of Antiemetic drugs | 48 hours | the use of antiemetic drugs. |
| the score of quality of recovery-15 items | 48 hours | the score of quality of recovery-15 items(QoR-15) |
| Condition of sedation | 48 hours | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 month | 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). |
Countries
China
Contacts
Primary Contactshinan deng, master
Backup Contacte wang, doctor
Outcome results
None listed