Analgesia, Patient-ControlledPhase 4NCT03685188
Oxycodone and Sufentanil for Analgesia in Hip Surgery
A Phase 4 study testing Oxycodone Hydrochloride and Sufentanil Citrate in people with Analgesia, Patient-Controlled, run by West China Hospital at 1 site in China.
Trial 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'… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia, Patient-Controlled
- What is being tested?
- Oxycodone Hydrochloride and Sufentanil Citrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 31 Jul 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing unilateral hip surgery, sign the "informed consent form".
- Age above 18 years old, with both genders.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Analgesia, Patient-Controlled
- Being tested
- Oxycodone Hydrochloride, Sufentanil Citrate
- Keywords
- Randomized controlled trial, oxycodone, sufentanil, patient-controlled intravenous analgesia, hip surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone HydrochlorideDrug
Subjects will receive patient' controlled intravenous analgesia in analgesic pump with 0.4 mg/ml of oxycodone for postoperative analgesia.
Sufentanil CitrateDrug
Subjects will receive patient' controlled intravenous analgesia in analgesic pump with 2 μg/ml of sufentanil for postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone group | Experimental | PCIA is formulated at 0.4 mg/ml of oxycodone. Receives: Drug: Oxycodone Hydrochloride |
| Sufentanil group | Active comparator | PCIA is formulated at 2 μg/ml of sufentanil. Receives: Drug: Sufentanil Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative numerical rating scales (NRS) at rest
Resting NRS pain scores at 2 h after surgery.
Measured: Up to 72 hours after operation
Secondary outcomes (16)
Incidence of post operative nausea and vomiting (PONV)
The proportion of subjects who experienced PONV
Measured: Up to 72 hours 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.
Measured: 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
Measured: Up to 30 days 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
Measured: Up to 72 hours after operation
Postoperative NRS on movement
Postoperative NRS pain score on movement, up to 72hr.
Measured: 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.
Measured: Up to 30 days after operation
Motion of hip joints
Range of motion of hip joints during 3 days after operation.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Up to 72 hours after operation
Residual amount of drug
Residual amount of drug in the analgesic pump.
Measured: Up to 72 hours after operation
Postoperative analgesics requirement
Postoperative analgesics requirement during 3 days after operation
Measured: Up to 72 hours after operation
Total in-hospital cost.
Total hospitalization expenses after the destruction of costly consumables in orthopedic operation.
Measured: Up to 30 days after operation
Length of stay (LOS) in hospital
Time frame from the day of hospital admission to discharge from the hospital (unit: days)
Measured: Up to 30 days after operation
Postoperative LOS
Time frame from the day of operation to discharge from the hospital (unit: days).
Measured: Up to 30 days after operation
Re-admission rate
The incidence of re-admission within 30 days after surgery.
Measured: Up to 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 Dec 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Analgesia, Patient-ControlledStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren Liao, West China Hospital
- Investigators
- Ren Liao, M.D, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685188
- Sponsor's protocol ID
- WCH2018086
- Status last verified
- Oct 2024
- First submitted
- 13 Sep 2018
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liao C, Zhu H, Zhong J, Lai X, Zhang B, Liao R. Patient Controlled Intravenous Analgesia with Oxycodone or Sufentanil After Hip Surgery: Study Protocol for a Multi-Centered, Randomized Controlled Trial. J Clin Med. 2025 Feb 25;14(5):1525. doi: 10.3390/jcm14051525.
PubMed 40095065
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oxycodone and Sufentanil for Analgesic Efficacy After Hip Surgery: a Prospective, Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03685188
- Acronym / sponsor ID
- WCH2018086
- Conditions
- Analgesia, Patient-Controlled
- Keywords
- Randomized controlled trial, oxycodone, sufentanil, patient-controlled intravenous analgesia, hip surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone group | Experimental | Drug: Oxycodone HydrochloridePCIA is formulated at 0.4 mg/ml of oxycodone. |
| Sufentanil group | Active comparator | Drug: Sufentanil CitratePCIA is formulated at 2 μg/ml of sufentanil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing unilateral hip surgery, sign the "informed consent form".
- Age above 18 years old, with both genders.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone HydrochlorideSubjects will receive patient' controlled intravenous analgesia in analgesic pump with 0.4 mg/ml of oxycodone for postoperative analgesia. | Drug | Oxycodone group |
| Sufentanil CitrateSubjects will receive patient' controlled intravenous analgesia in analgesic pump with 2 μg/ml of sufentanil for postoperative analgesia. | Drug | Sufentanil group |
Primary outcome
Postoperative numerical rating scales (NRS) at rest
Time frame: Up to 72 hours after operation
Resting NRS pain scores at 2 h after surgery.
16 secondary outcomes
Incidence of post operative nausea and vomiting (PONV)
Time frame: Up to 72 hours after operation
The severity of first PONV and the most severe PONV
Time frame: Up to 30 days after operation
Time from the end of operation to the first onset of PONV
Time frame: Up to 30 days after operation
Postoperative numerical rating scales (NRS) at rest
Time frame: Up to 72 hours after operation
Postoperative NRS on movement
Time frame: Up to 72 hours after operation
Postoperative complications
Time frame: Up to 30 days after operation
Motion of hip joints
Time frame: Up to 72 hours after operation
Straight leg raising time
Time frame: Up to 72 hours after operation
Ground exercise time
Time frame: Up to 72 hours after operation
Mobilization time
Time frame: Up to 72 hours after operation
Residual amount of drug
Time frame: Up to 72 hours after operation
Postoperative analgesics requirement
Time frame: Up to 72 hours after operation
Total in-hospital cost.
Time frame: Up to 30 days after operation
Length of stay (LOS) in hospital
Time frame: Up to 30 days after operation
Postoperative LOS
Time frame: Up to 30 days after operation
Re-admission rate
Time frame: Up to 30 days after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Derived from this study: PubMed 40095065Liao C, Zhu H, Zhong J, Lai X, Zhang B, Liao R. Patient Controlled Intravenous Analgesia with Oxycodone or Sufentanil After Hip Surgery: Study Protocol for a Multi-Centered, Randomized Controlled Trial. J Clin Med. 2025 Feb 25;14(5):1525. doi: 10.3390/jcm14051525.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ren Liao, M.D principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone Hydrochloride and Sufentanil Citrate in people with Analgesia, Patient-Controlled, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative numerical rating scales (NRS) at rest (time frame: Up to 72 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03685188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.