Pain, PostoperativePhase 4NCT03019562
Oxycodone vs. Fentanyl in Early Postoperative Pain After Total Hip Replacement
A Phase 4 study testing Oxycodone and Fentanyl in people with Pain, Postoperative, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
Oxycodone is one of the most widely used opioids for pain treatment. Many studies demonstrated good efficacy of oxycodone on postoperative pain. In this study, we assess the efficacy and side effects of bolus intravenous of oxycodone injection compared to those of fentanyl in patients after total hip replacement… Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Oxycodone and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to Dec 2017
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19-65 years of age
- ASA physical status classification I or II
- Scheduled for total hip replacement surgery
Who cannot join
- Allergic to study drugs
- Patient with asthma or COPD, patient who is severely respiratory depressed
- Renal of hepatic insufficiency
- Epileptic status
- Intracranial lesion associated with increased intracranial pressure
- Acute abdomen, patient who has diagnosed paralytic ileus or suspicious ileus
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Hospital
Seoul, 02447
Youngsoon Kim, 958-8589, ys.kim@khu.ac.kr
About this study
Official title: Oxycodone vs. Fentanyl in the Treatment of Early Postoperative Pain After Total Hip Replacement
Oxycodone is one of the most widely used opioids for pain treatment. Many studies demonstrated good efficacy of oxycodone on postoperative pain. In this study, we assess the efficacy and side effects of bolus intravenous of oxycodone injection compared to those of fentanyl in patients after total hip replacement surgery.
Read the detailed description
Oxycodone is one of the most widely used opioids for pain treatment. There have been several studies on the efficacy and side effects of oxycodone. Oxycodone has been known to have the same potency with morphine. Many studies demonstrated good efficacy of oxycodone on postoperative pain. In this study, we designed a prospective, randomized, and double-blind study to assess the efficacy and side effects of bolus intravenous of oxycodone injection compared to those of fentanyl in patients who underwent the total hip replacement surgery.
- Conditions
- Pain, Postoperative
- Being tested
- Oxycodone, Fentanyl
- Keywords
- postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Also called Oxynorm
4mg of oxycodone iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA)
FentanylDrug
50ug of fentanyl iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA),
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone | Experimental | 4mg of oxycodone iv bolus Receives: Drug: Oxycodone |
| Fentanyl | Active comparator | 50ug of fentanyl iv bolus Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain measurement using Numeric Rating Scale(NRS)
Measure postoperative pain using NRS at the PostAnesthesia Care Unit(PACU)
Measured: Immediately after surgery
Secondary outcomes (1)
Additional doses of fentanyl for pain management
0-6 hours, 6-12 hours, 12-24 hours, 24-48 hours after surgery
Measured: From immediately after surgery to 2 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mi Kyeong Kim, Kyunghee University Medical Center
- Investigators
- Mi Kyeong Kim, MD, PhD, Principal investigator, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019562
- Sponsor's protocol ID
- KHUH 2016-09-047
- Status last verified
- Jan 2017
- First submitted
- 11 Jan 2017
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxycodone vs. Fentanyl in the Treatment of Early Postoperative Pain After Total Hip Replacement
- ClinicalTrials.gov ID
- NCT03019562
- Acronym / sponsor ID
- KHUH 2016-09-047
- Conditions
- Pain, Postoperative
- Keywords
- postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- 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 is one of the most widely used opioids for pain treatment. Many studies demonstrated good efficacy of oxycodone on postoperative pain. In this study, we assess the efficacy and side effects of bolus intravenous of oxycodone injection compared to those of fentanyl in patients after total hip replacement surgery.
Detailed description
Oxycodone is one of the most widely used opioids for pain treatment. There have been several studies on the efficacy and side effects of oxycodone. Oxycodone has been known to have the same potency with morphine. Many studies demonstrated good efficacy of oxycodone on postoperative pain. In this study, we designed a prospective, randomized, and double-blind study to assess the efficacy and side effects of bolus intravenous of oxycodone injection compared to those of fentanyl in patients who underwent the total hip replacement surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone | Experimental | Drug: Oxycodone4mg of oxycodone iv bolus |
| Fentanyl | Active comparator | Drug: Fentanyl50ug of fentanyl iv bolus |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19-65 years of age
- ASA physical status classification I or II
- Scheduled for total hip replacement surgery
Key exclusion criteria (7 listed)
- Allergic to study drugs
- Patient with asthma or COPD, patient who is severely respiratory depressed
- Renal of hepatic insufficiency
- Epileptic status
- Intracranial lesion associated with increased intracranial pressure
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 |
|---|---|---|
| OxycodoneAlso: Oxynorm4mg of oxycodone iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA) | Drug | Oxycodone |
| Fentanyl50ug of fentanyl iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA), | Drug | Fentanyl |
Primary outcome
Postoperative pain measurement using Numeric Rating Scale(NRS)
Time frame: Immediately after surgery
Measure postoperative pain using NRS at the PostAnesthesia Care Unit(PACU)
1 secondary outcome
Additional doses of fentanyl for pain management
Time frame: From immediately after surgery to 2 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Pain, Postoperative
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
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.
Mi Kyeong Kim, MD, PhD principal investigator
Kyunghee University Medical Center
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 and Fentanyl in people with Pain, Postoperative, run by Kyunghee University Medical Center at 1 site in South Korea.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Jan 2017. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youngsoon Kim, MD, PhD (+82-2-958-8598, ys.kim@khu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain measurement using Numeric Rating Scale(NRS) (time frame: Immediately after surgery). 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 12 Jan 2017.