Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT03685188

Oxycodone and Sufentanil for Analgesia in Hip Surgery

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing unilateral hip surgery, sign the "informed consent form".
  • Age above 18 years old, with both genders.

Exclusion criteria

  • Pregnant or lactating women.
  • Patient with history of drug abuse, including but not limited to opioids, amphetamines, ketamine, etc.
  • Allergic to opioids or any other anesthetic agent.
  • History or family history of malignant hyperthermia.
  • Have history of nervous system diseases such as peripheral neuropathy, psychiatric mental illness, or postoperative delirium.
  • Other conditions that the investigators consider unsuitable for participation in the study, such as Parkinson's disease, unable to communicate, or impairment of cognitive function etc.
  • Participation in another trial in the past three months.

Treatment and study plan

Oxycodone hydrochloride

Drug

Subjects will receive patient' controlled intravenous analgesia in analgesic pump with 0.4 mg/ml of oxycodone for postoperative analgesia.

Sufentanil Citrate

Drug

Subjects will receive patient' controlled intravenous analgesia in analgesic pump with 2 μg/ml of sufentanil for postoperative analgesia.

Primary outcomes

  1. Postoperative numerical rating scales (NRS) at rest

    Time frame: Up to 72 hours after operation

    Resting NRS pain scores at 2 h after surgery.

Secondary outcomes

  1. Incidence of post operative nausea and vomiting (PONV)

    Time frame: Up to 72 hours after operation

    The proportion of subjects who experienced PONV

  2. 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.

  3. 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

  4. Postoperative numerical rating scales (NRS) at rest

    Time frame: Up to 72 hours after operation

    Postoperative resting NRS pain scores at 30 min, 6h, 24h, 48h, and 72h after the surgery

  5. Postoperative NRS on movement

    Time frame: Up to 72 hours after operation

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

  6. Postoperative complications

    Time frame: Up to 30 days after operation

    Incidence of postoperative adverse reactions and complications, which are divided into five grades:

    • Grade Ⅰ : Recovery after temporary treatment, e.g., postoperative anxiety, insomnia.
    • Grade Ⅱ : Prolonged hospitalization, e.g., pulmonary infection requiring antibiotics or other treatment, surgical wound infection requiring wound deb-ridement.
    • 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.
    • Grade Ⅳ: Life threatening complications resulting in significantly de-creased quality of life, e.g., myocardial infarction, stroke that left with paralytic limbs.
    • Grade Ⅴ: All-cause mortality by 30 days after operation.
  7. Motion of hip joints

    Time frame: Up to 72 hours after operation

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

  8. 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).

  9. 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).

  10. 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).

  11. Residual amount of drug

    Time frame: Up to 72 hours after operation

    Residual amount of drug in the analgesic pump.

  12. Postoperative analgesics requirement

    Time frame: Up to 72 hours after operation

    Postoperative analgesics requirement during 3 days after operation

  13. Total in-hospital cost.

    Time frame: Up to 30 days after operation

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

  14. 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)

  15. Postoperative LOS

    Time frame: Up to 30 days after operation

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

  16. Re-admission rate

    Time frame: Up to 30 days after operation

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

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Comparison of Oxycodone and Sufentanil for Analgesic Efficacy After Hip Surgery: a Prospective, Multicenter Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Sep 26, 2018
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.