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Oxycodone and Sufentanil for Analgesia in Hip Surgery

يمكن للمستخدمين المسجلين فقط ترجمة المقالات
الدخول التسجيل فى الموقع
يتم حفظ الارتباط في الحافظة
الحالة
الرعاة
West China Hospital

الكلمات الدالة

نبذة مختصرة

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.

وصف

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.

تواريخ

آخر التحقق: 05/31/2019
تم الإرسال لأول مرة: 09/12/2018
تم إرسال التسجيل المقدر: 09/23/2018
أول نشر: 09/25/2018
تم إرسال آخر تحديث: 06/12/2019
آخر تحديث تم نشره: 06/16/2019
تاريخ بدء الدراسة الفعلي: 11/30/2018
تاريخ الإنجاز الأساسي المقدر: 12/30/2021
التاريخ المتوقع لانتهاء الدراسة: 07/30/2022

حالة أو مرض

Analgesia, Patient-Controlled

التدخل / العلاج

Drug: Oxycodone group

Drug: Sufentanil group

مرحلة

مرحلة 4

مجموعات الذراع

ذراعالتدخل / العلاج
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.

معايير الأهلية

الأعمار المؤهلة للدراسة 18 Years إلى 18 Years
الأجناس المؤهلة للدراسةAll
يقبل المتطوعين الأصحاءنعم
المعايير

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

النتيجة

مقاييس النتائج الأولية

1. Postoperative numerical rating scales (NRS) at rest [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.

2. Incidence of post operative nausea and vomiting (PONV) [Up to 30 days after operation]

The proportion of subjects who experienced PONV

مقاييس النتائج الثانوية

1. Postoperative NRS on movement [Up to 72 hours after operation]

Postoperative NRS pain score on movement, up to 72hr.

2. Postoperative complications [Up to 30 days after operation]

Incidence of postoperative adverse reactions and complications

3. Residual amount of drug [Up to 72 hours after operation]

Residual amount of drug in the analgesic pump.

4. 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)

5. Postoperative LOS [Up to 30 days after operation]

Time frame from the day of operation to discharge from the hospital (unit: days).

6. Re-admission rate [Up to 30 days after operation]

The incidence of re-admission within 30 days after surgery.

7. Total in-hospital cost. [Up to 30 days after operation]

Total hospitalization expenses after the destruction of costly consumables in orthopedic operation.

8. 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

9. 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.

10. Motion of hip joints [Up to 72 hours after operation]

Range of motion of hip joints during 3 days after operation.

11. 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).

12. 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).

13. 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).

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