Ignite Creation Date:
2024-05-06 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03685188
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-10
First Post:
2018-09-13
Brief Title:
Oxycodone and Sufentanil for Analgesia in Hip Surgery
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
Comparison of Oxycodone and Sufentanil for Analgesic Efficacy After Hip Surgery a Prospective Multicenter Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We design this randomized controlled trial to compare the safety and efficacy of Oxycodone and Sufentanil for postoperative patient-controlled analgesia in patients undergoing hip surgery with a view to finding the optimal postoperative analgesic regime with fewer adverse reactions and promoting patients rehabilitation
Detailed Description:
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 ie 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 patients 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
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 ie 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None