Pain, PostoperativePhase 4NCT02272660
Parecoxib for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty
A Phase 4 study testing Parecoxib sodium and Normal saline injection in people with Pain, Postoperative, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Parecoxib sodium and Normal saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Aug 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients who have underwent primary unilateral total knee arthroplasty (TKA) and total hip arthroplasty (THA).
- Age between 18-65 years.
- Chinese ethnicity.
Who cannot join
- patients who underwent a reversion or a previous TKA or THA, emergency TKA, or TKA as result of a trauma.
- patient exhibited allergy to parecoxib sodium.
- lactating or pregnant.
- any other conditions not suitable for surgery as evaluated by the surgeon in charge.
Trial locations and contacts
1 site in 1 country.
China1 site
The Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
About this study
Official title: Perioperative Parecoxib Administration for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty-A Randomized, Placebo-controlled Trial
Evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.
Read the detailed description
Non-steroid anti-inflammatory drugs are recommended for multimodal postoperative pain management.
We evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.
- Conditions
- Pain, Postoperative
- Being tested
- Parecoxib sodium, Normal saline injection
- Keywords
- preemptive analgesia, parecoxib sodium, total knee arthroplasty, total hip arthroplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parecoxib sodiumDrug
Also called Dynastat
The patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision, 9:00 pm on the operation day as well as 9:00 am and 9:00 pm for the next two days after the operation, along with PCIA morphine.
Normal saline injectionDrug
Also called Physiological saline
The patients in the control group received 2 mL normal saline injection 30 minutes before Normal saline injection incision, 9:00 pm on the operation day as well as 9:00 am and 9:00 pm for the next two days after the operation, along with PCIA morphine.
| Study group | Role | What they receive |
|---|---|---|
| Parecoxib sodium | Experimental | The patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision. Receives: Drug: Parecoxib sodium |
| Normal saline injection | Placebo comparator | The control group received 2 mL normal saline injection at the same time point. Receives: Drug: Normal saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the Morphine consumption in each group patients
Measured: 4 hours to 6 days after the surgery
Secondary outcomes (3)
To evaluate Patient-Controlled Intravenous Analgesia (PCIA) duration
Measured: 4 hours to 6 days after the surgery
To evaluate the Visual Analog Scale (VAS) in each group patients underwent total knee arthroplasty and total hip arthroplasty
Measured: 4 hours to 6 days after the surgery
Function recovery of knee Range of Motion (ROM) for patients received surgery
Measured: 3 and 6 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionAug 2015
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.
- More trials run by Peking Union Medical College 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong Wu, Peking Union Medical College Hospital
- Investigators
- Zhihong Wu, Prof, Principal investigator, PUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272660
- Sponsor's protocol ID
- S-503
- Status last verified
- Aug 2015
- First submitted
- 17 Oct 2014
- Last updated
- 28 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Parecoxib Administration for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty-A Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02272660
- Acronym / sponsor ID
- S-503
- Conditions
- Pain, Postoperative
- Keywords
- preemptive analgesia, parecoxib sodium, total knee arthroplasty, total hip arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Oct 2014 (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.
Evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.
Detailed description
Non-steroid anti-inflammatory drugs are recommended for multimodal postoperative pain management.
We evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parecoxib sodium | Experimental | Drug: Parecoxib sodiumThe patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision. |
| Normal saline injection | Placebo comparator | Drug: Normal saline injectionThe control group received 2 mL normal saline injection at the same time point. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients who have underwent primary unilateral total knee arthroplasty (TKA) and total hip arthroplasty (THA).
- Age between 18-65 years.
- Chinese ethnicity.
Key exclusion criteria (4 listed)
- patients who underwent a reversion or a previous TKA or THA, emergency TKA, or TKA as result of a trauma.
- patient exhibited allergy to parecoxib sodium.
- lactating or pregnant.
- any other conditions not suitable for surgery as evaluated by the surgeon in charge.
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 |
|---|---|---|
| Parecoxib sodiumAlso: DynastatThe patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision, 9:00 pm on the operation day as well as 9:00 am and 9:00 pm for the next two days after the operation, along with PCIA morphine. | Drug | Parecoxib sodium |
| Normal saline injectionAlso: Physiological salineThe patients in the control group received 2 mL normal saline injection 30 minutes before Normal saline injection incision, 9:00 pm on the operation day as well as 9:00 am and 9:00 pm for the next two days after the operation, along with PCIA morphine. | Drug | Normal saline injection |
Primary outcome
To evaluate the Morphine consumption in each group patients
Time frame: 4 hours to 6 days after the surgery
3 secondary outcomes
To evaluate Patient-Controlled Intravenous Analgesia (PCIA) duration
Time frame: 4 hours to 6 days after the surgery
To evaluate the Visual Analog Scale (VAS) in each group patients underwent total knee arthroplasty and total hip arthroplasty
Time frame: 4 hours to 6 days after the surgery
Function recovery of knee Range of Motion (ROM) for patients received surgery
Time frame: 3 and 6 days after the surgery
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 28 Aug 2015.
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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.
Zhihong Wu, Prof principal investigator
PUMC
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 Parecoxib sodium and Normal saline injection in people with Pain, Postoperative, run by Peking Union Medical College 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 3 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 28 Aug 2015. 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. Some participants in this study may receive a placebo. 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?
To evaluate the Morphine consumption in each group patients (time frame: 4 hours to 6 days after the 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 28 Aug 2015.