Oxycodone and Sufentanil for Analgesia in Hip Surgery
Λέξεις-κλειδιά
Αφηρημένη
Περιγραφή
Hip surgery is a common type of orthopedic surgery. The pathologies are complex, including chronic conditions such as femoral head necrosis, primary hip dysplasia, hip joint osteoarthritis and rheumatoid arthritis, as well as acute diseases such as femoral neck fractures and intertrochanteric fractures. The surgical treatment includes closed reduction and internal fixation, open reduction and internal fixation, hemiarthroplasty (femoral head replacement), and total hip arthroplasty, etc. The population of patients undergoing hip surgery has a high proportion of elderly (>65 years old), with multiple preoperative comorbidities, and significant postoperative pain. We must achieve the balance between the providing sufficient analgesia and minimizing associated adverse reactions perioperatively for such group of patients, therefore promoting patients' rehabilitation.
Sufentanil, a pure μ receptor agonist with active metabolite, is a long-acting strong opioid which has high analgesic efficacy. It is commonly used in anesthesia practice, not only for intraoperative analgesia, but also postoperative pain relief, i.e. a popular drug of choice used for Patient Control Intravenous Analgesia (PCIA). However, sufentanil is associated with high incidence of postoperative nausea and vomiting (PONV), respiratory depression and other adverse reactions, which could negatively affect the patient's analgesic satisfaction, and compromise the course of postoperative recovery. It is important to establish an effective and safe postoperative analgesic regime that can achieve the comparable analgesic efficacy with reduced incidence of adverse reactions. Oxycodone is a semi-synthetic opioid which is extracted from the thebaine, it activates both μ and κ opioid receptors. It has been reported to have good analgesic effect and lower incidence of adverse reactions such as PONV in comparison with Morphine, and could be a reasonable option for PCIA. As Oxycodone can agonize κ receptors and reduce visceral pain, most of the existing studies on Oxycodone are focused on laparoscopic cholecystectomy and other abdominal surgeries, with the average age of study patients is between 40 to 55 years old, and also lack of large sample studies.
Based on the abovementioned literatures, we propose the hypothesis that in hip surgery, compared with Sufentanil PCIA, the equipotency dose of Oxycodone PCIA can achieve the same postoperative analgesic efficacy and may also reduce the incidence of adverse reactions associated with opioids.
Ημερομηνίες
| Τελευταία επαλήθευση: | 05/31/2019 |
| Πρώτα υποβλήθηκε: | 09/12/2018 |
| Υποβλήθηκε εκτιμώμενη εγγραφή: | 09/23/2018 |
| Δημοσιεύτηκε για πρώτη φορά: | 09/25/2018 |
| Υποβλήθηκε τελευταία ενημέρωση: | 06/12/2019 |
| Δημοσιεύτηκε η τελευταία ενημέρωση: | 06/16/2019 |
| Ημερομηνία έναρξης της πραγματικής μελέτης: | 11/30/2018 |
| Εκτιμώμενη κύρια ημερομηνία ολοκλήρωσης: | 12/30/2021 |
| Εκτιμώμενη ημερομηνία ολοκλήρωσης μελέτης: | 07/30/2022 |
Κατάσταση ή ασθένεια
Παρέμβαση / θεραπεία
Drug: Oxycodone group
Drug: Sufentanil group
Φάση
Ομάδες βραχιόνων
| Μπράτσο | Παρέμβαση / θεραπεία |
|---|---|
| Experimental: Oxycodone group PCIA is formulated at 0.4 mg/ml of oxycodone. | Drug: Oxycodone group Subjects will receive patient' controlled intravenous analgesia in analgesic pump with 0.4 mg/ml of oxycodone for postoperative analgesia. |
| Active Comparator: Sufentanil group PCIA is formulated at 2 μg/ml of sufentanil. | Drug: Sufentanil group Subjects will receive patient' controlled intravenous analgesia in analgesic pump with 2 μg/ml of sufentanil for postoperative analgesia. |
Κριτήρια καταλληλότητας
| Επιλέξιμες ηλικίες για μελέτη | 18 Years Προς την 18 Years |
| Φύλα επιλέξιμα για μελέτη | All |
| Δέχεται υγιείς εθελοντές | Ναί |
| Κριτήρια | Inclusion Criteria: - Patients undergoing unilateral hip surgery, sign the "informed consent form" - Age above 18 years old Exclusion Criteria: - Pregnant or lactating women - Patients with history of drug abuse, including but not limited to opioids, amphetamines, ketamine, etc - Allergic to opioids - Have history of nervous system diseases such as peripheral neuropathy, or psychiatric mental illness - Other conditions that the investigators consider unsuitable for participation in the study, such as deaf, Parkinson's disease, and difficult to communication etc |
Αποτέλεσμα
Πρωτεύοντα αποτελέσματα
1. Postoperative numerical rating scales (NRS) at rest [Up to 72 hours after operation]
2. Incidence of post operative nausea and vomiting (PONV) [Up to 30 days after operation]
Δευτερεύοντα αποτελέσματα
1. Postoperative NRS on movement [Up to 72 hours after operation]
2. Postoperative complications [Up to 30 days after operation]
3. Residual amount of drug [Up to 72 hours after operation]
4. Length of stay (LOS) in hospital [Up to 30 days after operation]
5. Postoperative LOS [Up to 30 days after operation]
6. Re-admission rate [Up to 30 days after operation]
7. Total in-hospital cost. [Up to 30 days after operation]
8. Time from the end of operation to the first onset of PONV [Up to 30 days after operation]
9. The severity of first PONV and the most severe PONV [Up to 30 days after operation]
10. Motion of hip joints [Up to 72 hours after operation]
11. Straight leg raising time [Up to 72 hours after operation]
12. Ground exercise time [Up to 72 hours after operation]
13. Mobilization time [Up to 72 hours after operation]
