Oxycodone and Sufentanil for Analgesia in Hip Surgery

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Analgesia, Patient-Controlled
• Intervention / Treatment: Drug: Oxycodone Hydrochloride; Drug: Sufentanil Citrate

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.

• Study Type: Interventional
• Enrollment (Estimated): 570
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative numerical rating scales (NRS) at rest	Resting NRS pain scores at 2 h after surgery.	Up to 72 hours after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative NRS on movement	Postoperative NRS pain score on movement, up to 72hr.	Up to 72 hours after operation
Residual amount of drug	Residual amount of drug in the analgesic pump.	Up to 72 hours after operation
Length of stay (LOS) in hospital	Time frame from the day of hospital admission to discharge from the hospital (unit: days)	Up to 30 days after operation
Postoperative LOS	Time frame from the day of operation to discharge from the hospital (unit: days).	Up to 30 days after operation
Re-admission rate	The incidence of re-admission within 30 days after surgery.	Up to 30 days after operation
Total in-hospital cost.	Total hospitalization expenses after the destruction of costly consumables in orthopedic operation.	Up to 30 days after operation
Time from the end of operation to the first onset of PONV	Time from the end of operation to the first onset of PONV	Up to 30 days after operation
The severity of first PONV and the most severe PONV	The severity of PONV is scored from 0 to 10, and 0 represents no PONV at all, and 10 represents very severe PONV.	Up to 30 days after operation
Motion of hip joints	Range of motion of hip joints during 3 days after operation.	Up to 72 hours after operation
Straight leg raising time	Time from the end of operation to the time that patient can raise his affected lower limb by himself (Unit: hour).	Up to 72 hours after operation
Ground exercise time	Time from the end of operation to the time that patient can do the ground exercise by himself (Unit: hour).	Up to 72 hours after operation
Mobilization time	Time frame from the end of operation to able to walk without external assistance (Walking aids such as crutches can be used, unit: hour).	Up to 72 hours after operation
Incidence of post operative nausea and vomiting (PONV)	The proportion of subjects who experienced PONV	Up to 72 hours after operation
Postoperative numerical rating scales (NRS) at rest	Postoperative resting NRS pain scores at 30 min, 6h, 24h, 48h, and 72h after the surgery	Up to 72 hours after operation
Postoperative complications	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.	Up to 30 days after operation
Postoperative analgesics requirement	Postoperative analgesics requirement during 3 days after operation	Up to 72 hours after operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of post operative nausea and vomiting (PONV)	The proportion of subjects who experienced PONV	Up to 72 hours after operation

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Principal Investigator: Ren Liao, M.D, West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Randomized controlled trial; sufentanil; oxycodone; hip surgery; patient-controlled intravenous analgesia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Oxycodone; Sufentanil; Dsuvia
• Other Study ID Numbers: WCH2018086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No