Total Hip ArthroplastyPhase 4NCT05602519
The Analgesic Efficacy of Oxycodone Hydrochloride Versus Fentanyl After Total Hip Arthroplasty:
A Phase 4 study testing propofol, rocuronium and fentanyl in people with Total Hip Arthroplasty and The Analgesic Efficacy, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Oxycodone showed similar or superior analgesic effects than fentanyl and was proposed as an alternative for fentanyl for pain control in the postoperative period. However, it was mainly directed to control visceral pain, due to the mediation of analgesic effects by the kappa receptors. Read more about this study
- Who is it for?
- Ages 28 to 62 years
- Conditions the study is for
- Total Hip Arthroplasty, The Analgesic Efficacy
- What is being tested?
- propofol, rocuronium and fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2022to 30 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 28 to 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 28-62 years old,
- Both genders, American Society of Anesthesiologists (ASA) physical status classification I or II who scheduled for elective total hip surgery.
Who cannot join
- Patients with history of any kind of drug allergy.
- drug abuse.
- psychological or other emotional problems,
- renal and hepatic chronic disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Facualty of Medicine (Damietta), Al Azhar University
Damietta, 34711
About this study
Official title: The Analgesic Efficacy and Safety of Oxycodone Hydrochloride Versus Fentanyl After Total Hip Arthroplasty: A Randomized Triple-Blind Trial
Oxycodone showed similar or superior analgesic effects than fentanyl and was proposed as an alternative for fentanyl for pain control in the postoperative period. However, it was mainly directed to control visceral pain, due to the mediation of analgesic effects by the kappa receptors. However, few studies compared the oxycodone to fentanyl for postoperative pain relief in patients undergoing total hip arthroplasty (replacement). Therefore, we established this randomized study to compare the efficacy of oxycodone and fentanyl for relief of postoperative pain after total hip arthroplasty (replacement).
- Conditions
- Total Hip Arthroplasty, The Analgesic Efficacy
- Being tested
- propofol, rocuronium and fentanyl
- Keywords
- Oxycodone Hydrochloride, Fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol, rocuronium and fentanylDrug
In fentanyl group (36 patients), 50 ug of fentanyl, and in oxycodone group, 4 mg of oxycodone will be administered 20 minutes before the end of the surgery, in triple blind manner.
| Study group | Role | What they receive |
|---|---|---|
| Group fentanyl | Active comparator | Patients will receive 50 ug of fentanyl 20 min before the end of surgery. Receives: Drug: propofol, rocuronium and fentanyl |
| Group oxycodone | Active comparator | Patients will receive 4 mg of oxycodone 20 min before the end of surgery. Receives: Drug: propofol, rocuronium and fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving A post-anesthesia care unit (PACU) pain score.
The visual analogue scale (VAS) will be used for assessment of postoperative pain severity (0 for no pain and 10 for the most severe pain).
Measured: 48 hours
Secondary outcomes (3)
Hemodynamics
Mean arterial blood pressure and heart rate will be recorded at baseline and every 5 min till the end of procedure.
Measured: 48 hours
Postoperative side effects
Any side effects will be documented. Postoperative nausea and vomiting (if occurred) will be treated by intravenous administration of metoclopramide (10mg).
Measured: 48 hours
Postoperative consumption of opioid
The overall dose of fentanyl administrated in the first 48 postoperative hours will be documented at 6, 12, 24 and 48 hours.
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start10 Nov 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602519
- Sponsor's protocol ID
- IRB 00012367-22-010-005
- Status last verified
- Aug 2023
- First submitted
- 28 Oct 2022
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared with a reasonable request with corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy and Safety of Oxycodone Hydrochloride Versus Fentanyl After Total Hip Arthroplasty: A Randomized Triple-Blind Trial
- ClinicalTrials.gov ID
- NCT05602519
- Acronym / sponsor ID
- IRB 00012367-22-010-005
- Conditions
- Total Hip Arthroplasty, The Analgesic Efficacy
- Keywords
- Oxycodone Hydrochloride, Fentanyl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 2 Nov 2022 (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.
Oxycodone showed similar or superior analgesic effects than fentanyl and was proposed as an alternative for fentanyl for pain control in the postoperative period. However, it was mainly directed to control visceral pain, due to the mediation of analgesic effects by the kappa receptors. However, few studies compared the oxycodone to fentanyl for postoperative pain relief in patients undergoing total hip arthroplasty (replacement). Therefore, we established this randomized study to compare the efficacy of oxycodone and fentanyl for relief of postoperative pain after total hip arthroplasty (replacement).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group fentanyl | Active comparator | Drug: propofol, rocuronium and fentanylPatients will receive 50 ug of fentanyl 20 min before the end of surgery. |
| Group oxycodone | Active comparator | Drug: propofol, rocuronium and fentanylPatients will receive 4 mg of oxycodone 20 min before the end of surgery. |
Who may qualify
- Ages
- 28 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients aged 28-62 years old,
- Both genders, American Society of Anesthesiologists (ASA) physical status classification I or II who scheduled for elective total hip surgery.
Key exclusion criteria (4 listed)
- Patients with history of any kind of drug allergy.
- drug abuse.
- psychological or other emotional problems,
- renal and hepatic chronic disease.
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 |
|---|---|---|
| propofol, rocuronium and fentanylIn fentanyl group (36 patients), 50 ug of fentanyl, and in oxycodone group, 4 mg of oxycodone will be administered 20 minutes before the end of the surgery, in triple blind manner. | Drug | Group fentanyl, Group oxycodone |
Primary outcome
Improving A post-anesthesia care unit (PACU) pain score.
Time frame: 48 hours
The visual analogue scale (VAS) will be used for assessment of postoperative pain severity (0 for no pain and 10 for the most severe pain).
3 secondary outcomes
Hemodynamics
Time frame: 48 hours
Postoperative side effects
Time frame: 48 hours
Postoperative consumption of opioid
Time frame: 48 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: Yes. Data can be shared with a reasonable request with corresponding author.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 propofol, rocuronium and fentanyl in people with Total Hip Arthroplasty and The Analgesic Efficacy, run by Al-Azhar University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 7 Aug 2023. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improving A post-anesthesia care unit (PACU) pain score. (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2023.