Pain, PostoperativePhase 4NCT02270437
Safety and Efficacy of Cocktail Periarticular Injection in Simultaneous Total Knee Arthroplasty
A Phase 4 study testing ropivacaine, fentanyl, adrenaline in people with Pain, Postoperative, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
We investigated the safety and efficacy of the bilateral periarticular cocktail injection at a reduced dosage in patients undergoing simultaneous bilateral total knee arthroplasty. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- ropivacaine, fentanyl, adrenaline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- Jun 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with tricompartmental knee disease undergoing simultaneous bilateral TKA
Who cannot join
- diabetes mellitus
- neuromuscular deficit
- a known allergy to one of the drugs being injected
- a history of cardiac disease or arrhythmia requiring special monitoring
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
About this study
Official title: Safety and Efficacy of Cocktail Periarticular Injection for Pain Management in Simultaneous Bilateral Total Knee Arthroplasty- A Prospective, Randomized Trial
We investigated the safety and efficacy of the bilateral periarticular cocktail injection at a reduced dosage in patients undergoing simultaneous bilateral total knee arthroplasty.
Read the detailed description
It is hypothesized that intraoperative periarticular injection with cocktail analgesics can reduce postoperative parenteral narcotics use and improve patient satisfaction following total knee arthroplasty.
A prospective, randomized trial is conducted to testify the hypothesis above by recruiting patients who go through simultaneous bilateral TKA and observing their postoperative analgesic consumption, visual analog scores and functional recovery. Potential side-effects of the multimodal drugs is also under observation.
- Conditions
- Pain, Postoperative
- Being tested
- ropivacaine, fentanyl, adrenaline
- Keywords
- total knee arthroplasty, cocktail analgesia, morphine consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaine, fentanyl, adrenalineDrug
Also called Naropin, AstraZeneca
The patients in the cocktail analgesia group received an injection of 200mg ropivacaine, 100ug fentanyl, and 0.25mg adrenaline into knee collateral ligaments, posterior aspect of the capsule, quadriceps tendon, patellar tendon, fat pad, periosteum, and synovium, along with PCIA morphine postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| cocktail analgesia | Experimental | The local infiltration mixture of ropivacaine, fentanyl, adrenaline is used intra-articularly during operation. The patients in the cocktail analgesia group received an injection of 200mg ropivacaine, 100ug fentanyl, and 0.25mg adrenaline into knee collateral ligaments, posterior aspect of the capsule, quadriceps tendon, patellar tendon, fat pad, periosteum, and synovium, along with PCIA morphine postoperatively. Receives: Drug: ropivacaine, fentanyl, adrenaline |
| no cocktail injection | No intervention | The patients in the no cocktail injection group received PCIA morphine postoperatively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the Morphine consumption and PCIA duration
Measured: 12 hours to 3 days after the surgery
Secondary outcomes (2)
To evaluate the visual analog scale (VAS) in each group patients underwent total knee arthroplasty
Measured: 4 hours to 5 days after the surgery
Function recovery evaluation for patients received surgery
Measured: 1, 3 and 5 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 posted21 Oct 2014 (estimated)
- Study startJun 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 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
- Wu Zhihong, Prof, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270437
- Sponsor's protocol ID
- CBX 726
- Status last verified
- Aug 2015
- First submitted
- 2 Aug 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
- Safety and Efficacy of Cocktail Periarticular Injection for Pain Management in Simultaneous Bilateral Total Knee Arthroplasty- A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT02270437
- Acronym / sponsor ID
- CBX 726
- Conditions
- Pain, Postoperative
- Keywords
- total knee arthroplasty, cocktail analgesia, morphine consumption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 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.
We investigated the safety and efficacy of the bilateral periarticular cocktail injection at a reduced dosage in patients undergoing simultaneous bilateral total knee arthroplasty.
Detailed description
It is hypothesized that intraoperative periarticular injection with cocktail analgesics can reduce postoperative parenteral narcotics use and improve patient satisfaction following total knee arthroplasty.
A prospective, randomized trial is conducted to testify the hypothesis above by recruiting patients who go through simultaneous bilateral TKA and observing their postoperative analgesic consumption, visual analog scores and functional recovery. Potential side-effects of the multimodal drugs is also under observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cocktail analgesia | Experimental | Drug: ropivacaine, fentanyl, adrenalineThe local infiltration mixture of ropivacaine, fentanyl, adrenaline is used intra-articularly during operation. The patients in the cocktail analgesia group received an injection of 200mg ropivacaine, 100ug fentanyl, and 0.25mg adrenaline into knee collateral ligaments, posterior aspect of the capsule, quadriceps tendon, patellar tendon, fat pad, periosteum, and synovium, along with PCIA morphine postoperatively. |
| no cocktail injection | No intervention | –The patients in the no cocktail injection group received PCIA morphine postoperatively. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with tricompartmental knee disease undergoing simultaneous bilateral TKA
Key exclusion criteria (4 listed)
- diabetes mellitus
- neuromuscular deficit
- a known allergy to one of the drugs being injected
- a history of cardiac disease or arrhythmia requiring special monitoring
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 |
|---|---|---|
| ropivacaine, fentanyl, adrenalineAlso: Naropin, AstraZenecaThe patients in the cocktail analgesia group received an injection of 200mg ropivacaine, 100ug fentanyl, and 0.25mg adrenaline into knee collateral ligaments, posterior aspect of the capsule, quadriceps tendon, patellar tendon, fat pad, periosteum, and synovium, along with PCIA morphine postoperatively. | Drug | cocktail analgesia |
Primary outcome
To evaluate the Morphine consumption and PCIA duration
Time frame: 12 hours to 3 days after the surgery
2 secondary outcomes
To evaluate the visual analog scale (VAS) in each group patients underwent total knee arthroplasty
Time frame: 4 hours to 5 days after the surgery
Function recovery evaluation for patients received surgery
Time frame: 1, 3 and 5 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.
Wu Zhihong, Prof study director
Peking Union Medical College 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 ropivacaine, fentanyl, adrenaline 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 1 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. 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 and PCIA duration (time frame: 12 hours to 3 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.