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Oxycodone and Sufentanil for Analgesia in Hip Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03685188
Recruitment Status : Enrolling by invitation
First Posted : September 26, 2018
Last Update Posted : March 13, 2019
Information provided by (Responsible Party):
Ren Liao, 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.

Condition or disease Intervention/treatment Phase
Analgesia, Patient-Controlled Drug: Oxycodone Hydrochloride Drug: Sufentanil Citrate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Postoperative NRS on movement [ Time Frame: Up to 72 hours after operation ]
    Postoperative NRS pain score on movement, up to 72hr.

  2. Postoperative complications [ Time Frame: 30 days after operation ]
    Incidence of postoperative adverse reactions and complications

  3. Mobilization time [ Time Frame: Up to 3 days after operation ]
    Time frame from the end of operation to able to walk without external assistance (unit: hours).

  4. Residual amount of drug [ Time Frame: Up to 72 hours after operation ]
    Residual amount of drug in the analgesic pump.

  5. Length of stay (LOS) in hospital [ Time Frame: 60 days after operation ]
    Time frame from the day of hospital admission to discharge from the hospital (unit: days)

  6. Postoperative LOS [ Time Frame: 60 days after operation ]
    Time frame from the day of operation to discharge from the hospital (unit: days).

  7. Re-admission rate [ Time Frame: 30 days after operation ]
    The incidence of re-admission within 30 days after surgery.

  8. Total in-hospital cost. [ Time Frame: 60 days after operation ]
    Total hospitalization expenses after the destruction of costly consumables in orthopedic operation.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients undergoing 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03685188

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China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
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Principal Investigator: Ren Liao, M.D West China Hospital

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Responsible Party: Ren Liao, Associate professor, West China Hospital Identifier: NCT03685188     History of Changes
Other Study ID Numbers: WCH2018086
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Central Nervous System Depressants
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General