Oxycodone and Sufentanil for Analgesia in Hip Surgery
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|ClinicalTrials.gov Identifier: NCT03685188|
Recruitment Status : Enrolling by invitation
First Posted : September 26, 2018
Last Update Posted : June 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Analgesia, Patient-Controlled||Drug: Oxycodone Hydrochloride Drug: Sufentanil Citrate||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||570 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Comparison of Oxycodone and Sufentanil for Analgesic Efficacy After Hip Surgery: a Prospective, Multicenter Randomized Controlled Trial|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||July 31, 2022|
Experimental: Oxycodone group
PCIA is formulated at 0.4 mg/ml of oxycodone.
Drug: Oxycodone Hydrochloride
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 Citrate
Subjects will receive patient' controlled intravenous analgesia in analgesic pump with 2 μg/ml of sufentanil for postoperative analgesia.
- Postoperative numerical rating scales (NRS) at rest [ Time Frame: Up to 72 hours after operation ]Resting NRS pain scores at 30 min, 2 h, 6 h, 24 h, 48 h, and 72h after surgery.
- Incidence of post operative nausea and vomiting (PONV) [ Time Frame: Up to 30 days after operation ]The proportion of subjects who experienced PONV
- Postoperative NRS on movement [ Time Frame: Up to 72 hours after operation ]Postoperative NRS pain score on movement, up to 72hr.
- Postoperative complications [ Time Frame: Up to 30 days after operation ]Incidence of postoperative adverse reactions and complications
- Residual amount of drug [ Time Frame: Up to 72 hours after operation ]Residual amount of drug in the analgesic pump.
- Length of stay (LOS) in hospital [ Time Frame: Up to 30 days after operation ]Time frame from the day of hospital admission to discharge from the hospital (unit: days)
- Postoperative LOS [ Time Frame: Up to 30 days after operation ]Time frame from the day of operation to discharge from the hospital (unit: days).
- Re-admission rate [ Time Frame: Up to 30 days after operation ]The incidence of re-admission within 30 days after surgery.
- Total in-hospital cost. [ Time Frame: Up to 30 days after operation ]Total hospitalization expenses after the destruction of costly consumables in orthopedic operation.
- Time from the end of operation to the first onset of PONV [ Time Frame: Up to 30 days after operation ]Time from the end of operation to the first onset of PONV
- The severity of first PONV and the most severe PONV [ Time Frame: Up to 30 days after operation ]The severity of PONV is scored from 0 to 10, and 0 represents no PONV at all, and 10 represents very severe PONV.
- Motion of hip joints [ Time Frame: Up to 72 hours after operation ]Range of motion of hip joints during 3 days after operation.
- Straight leg raising time [ Time Frame: Up to 72 hours after operation ]Time from the end of operation to the time that patient can raise his affected lower limb by himself (Unit: hour).
- Ground exercise time [ Time Frame: Up to 72 hours after operation ]Time from the end of operation to the time that patient can do the ground exercise by himself (Unit: hour).
- Mobilization time [ Time Frame: Up to 72 hours after operation ]Time frame from the end of operation to able to walk without external assistance (Walking aids such as crutches can be used, unit: hour).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685188
|West China Hospital, Sichuan University|
|Chengdu, Sichuan, China, 610041|
|Principal Investigator:||Ren Liao, M.D||West China Hospital|