Oxycodone and Sufentanil for Analgesia in Hip Surgery
- Conditions
- Analgesia, Patient-Controlled
- Interventions
- Registration Number
- NCT03685188
- Lead Sponsor
- West China Hospital
- 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, 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 570
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oxycodone group Oxycodone Hydrochloride PCIA is formulated at 0.4 mg/ml of oxycodone. Sufentanil group Sufentanil Citrate PCIA is formulated at 2 μg/ml of sufentanil.
- Primary Outcome Measures
Name Time Method Postoperative numerical rating scales (NRS) at rest Up to 72 hours after operation Resting NRS pain scores at 2 h after surgery.
- Secondary Outcome Measures
Name Time Method Incidence of post operative nausea and vomiting (PONV) Up to 72 hours after operation The proportion of subjects who experienced PONV
The severity of first PONV and the most severe PONV 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.
Time from the end of operation to the first onset of PONV Up to 30 days after operation Time from the end of operation to the first onset of PONV
Postoperative numerical rating scales (NRS) at rest Up to 72 hours after operation Postoperative resting NRS pain scores at 30 min, 6h, 24h, 48h, and 72h after the surgery
Postoperative NRS on movement Up to 72 hours after operation Postoperative NRS pain score on movement, up to 72hr.
Postoperative complications Up to 30 days after operation Incidence of postoperative adverse reactions and complications, which are divided into five grades:
1. Grade Ⅰ ： Recovery after temporary treatment, e.g., postoperative anxiety, insomnia.
2. Grade Ⅱ ： Prolonged hospitalization, e.g., pulmonary infection requiring antibiotics or other treatment, surgical wound infection requiring wound deb-ridement.
3. Grade Ⅲ： Life threatening complications requiring intense treatment dur-ing hospitalization, and resulting in good functional recovery e.g., dialysis thera-py for acute renal insufficiency, mechanical ventilatory support for respiratory failure, or postoperative bleeding requiring re-operation.
4. Grade Ⅳ： Life threatening complications resulting in significantly de-creased quality of life, e.g., myocardial infarction, stroke that left with paralytic limbs.
5. Grade Ⅴ： All-cause mortality by 30 days after operation.Motion of hip joints Up to 72 hours after operation Range of motion of hip joints during 3 days after operation.
Straight leg raising time 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 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 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).
Residual amount of drug Up to 72 hours after operation Residual amount of drug in the analgesic pump.
Postoperative analgesics requirement Up to 72 hours after operation Postoperative analgesics requirement during 3 days after operation
Total in-hospital cost. Up to 30 days after operation Total hospitalization expenses after the destruction of costly consumables in orthopedic operation.
Length of stay (LOS) in hospital Up to 30 days after operation Time frame from the day of hospital admission to discharge from the hospital (unit: days)
Postoperative LOS Up to 30 days after operation Time frame from the day of operation to discharge from the hospital (unit: days).
Re-admission rate Up to 30 days after operation The incidence of re-admission within 30 days after surgery.
Trial Locations
- Locations (1)
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China