Pain, PostoperativeNCT05204056
Application of Iced Normal Saline Combined With Cocktail Perfusion in Total Knee Arthroplasty
A study testing iced normal saline, Tranexamic acid injection and Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusion in people with Pain, Postoperative and Blood Loss, Postoperative, run by Yantai Yuhuangding Hospital at 1 site in China.
Trial summary
Sixty patients undergoing TKA were divided into three groups, then three different intro-operative articular cavity perfusion treatment was given according to the randomized, double-blind and controlled rule. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pain, Postoperative, Blood Loss, Postoperative
- What is being tested?
- iced normal saline, Tranexamic acid injection and Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2018to 1 Aug 2018
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed primary knee osteoarthritis in stage IV by preoperative X-ray were included in present study. Kellgren-Lawrence Radiology standards for stage IV were listed as follows: obviously narrowed joint space; vast osteophytes are formed; severe osteosclerosis under the cartilage; bone hypertrophy and evident deformity
Who cannot join
- Subsequent arthritis (including rheumatoid arthritis, Gouty arthritis, traumatic arthritis, etc.) were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Iced Normal Saline Combined With Cocktail Perfusion in Total Knee Arthroplasty: Randomized Controlled Trial
Sixty patients undergoing TKA were divided into three groups, then three different intro-operative articular cavity perfusion treatment was given according to the randomized, double-blind and controlled rule. One way ANOVA analysis on visual analogue scale (VAS) score, functional recovery, drainage, and edema of the affected limb were performed to assess the efficiency of the treatment in the following three days after the operation.
Read the detailed description
Patients with confirmed primary knee osteoarthritis in stage IV by preoperative X-ray were included in present study, whilst subsequent arthritis (including rheumatoid arthritis, Gouty arthritis, traumatic arthritis, etc.) were excluded. After assessment, sixty qualified patients who voluntarily participating in this study have understood the research project were included in the present study and the corresponding consent forms were signed. Patients were randomly classified into three groups with different interventions, each group contains 20 patients. Group A: twenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline; Group B twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic; the left twenty patients were given joint cavity infusion therapy with 20ml tranexamic only as the control group. All the study personnel including the patients, their family members, the nursing staff and the leading operator were blind to the treatment allocation.
- Conditions
- Pain, Postoperative, Blood Loss, Postoperative
- Being tested
- iced normal saline, Tranexamic acid injection, Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusion
- Medical subject headings
- Pain, Postoperative, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iced normal salineDrug
Also called H19983149
Iced normal saline (20ml) was given intraoperative joint cavity infusion therapy
Tranexamic acid injectionDrug
Also called H43020565
20ml of tranexamic was given with iced normal saline for intraoperative joint cavity infusion.
Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusionOther
Cocktail was formulated during the operation by mixing Ropivacaine 150mg, Morphine 10mg and Epinephrine 1mg, then normal saline was used to dilute the mixture to 60ml. Then the cocktail mixture was applied for the joint cavity perfusion.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Twenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline. Receives: Drug: iced normal saline; Drug: Tranexamic acid injection |
| Group B | Experimental | Twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic Receives: Drug: iced normal saline; Drug: Tranexamic acid injection; Other: Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusion |
| Control group | Active comparator | Twenty patients were given joint cavity infusion therapy with 20ml tranexamic only as the control group Receives: Drug: Tranexamic acid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced pain
the pain after operation reduced significantly.
Measured: three days after operation
Secondary outcomes (1)
Reduced bleeding
The blood loss reduced significantly after operation.
Measured: 24 hours drainage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start2 Mar 2018
- Primary completion1 Jun 2018
- Study completion1 Aug 2018
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Recruited patients were divided into three groups with different recipes. Group A: twenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline; Group B twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic; the left twenty patients were given joint cavity infusion therapy with 20ml tranexamic only as the control group. Intravertebral anaesthesia was selected for the surgery and the operations were performed by the same surgical team. The average operation time was about 1.5 hours, which lasted from the compression of the tourniquet to completed wound dressing.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yantai Yuhuangding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laijian Sui, Doctor, Study chair, Yantai Yuhuangding Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204056
- Sponsor's protocol ID
- 2018-149
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2022
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Iced Normal Saline Combined With Cocktail Perfusion in Total Knee Arthroplasty: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05204056
- Acronym / sponsor ID
- 2018-149
- Conditions
- Pain, Postoperative, Blood Loss, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yantai Yuhuangding HospitalUniversity, hospital or other
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 24 Jan 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.
Sixty patients undergoing TKA were divided into three groups, then three different intro-operative articular cavity perfusion treatment was given according to the randomized, double-blind and controlled rule. One way ANOVA analysis on visual analogue scale (VAS) score, functional recovery, drainage, and edema of the affected limb were performed to assess the efficiency of the treatment in the following three days after the operation.
Detailed description
Patients with confirmed primary knee osteoarthritis in stage IV by preoperative X-ray were included in present study, whilst subsequent arthritis (including rheumatoid arthritis, Gouty arthritis, traumatic arthritis, etc.) were excluded. After assessment, sixty qualified patients who voluntarily participating in this study have understood the research project were included in the present study and the corresponding consent forms were signed. Patients were randomly classified into three groups with different interventions, each group contains 20 patients. Group A: twenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline; Group B twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic; the left twenty patients were given joint cavity infusion therapy with 20ml tranexamic only as the control group. All the study personnel including the patients, their family members, the nursing staff and the leading operator were blind to the treatment allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Recruited patients were divided into three groups with different recipes. Group A: twenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline; Group B twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic; the left twenty patients were given joint cavity infusion therapy with 20ml tranexamic only as the control group. Intravertebral anaesthesia was selected for the surgery and the operations were performed by the same surgical team. The average operation time was about 1.5 hours, which lasted from the compression of the tourniquet to completed wound dressing.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: iced normal saline, Drug: Tranexamic acid injectionTwenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline. |
| Group B | Experimental | Drug: iced normal saline, Drug: Tranexamic acid injection, Other: Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusionTwenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic |
| Control group | Active comparator | Drug: Tranexamic acid injectionTwenty patients were given joint cavity infusion therapy with 20ml tranexamic only as the control group |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with confirmed primary knee osteoarthritis in stage IV by preoperative X-ray were included in present study. Kellgren-Lawrence Radiology standards for stage IV were listed as follows: obviously narrowed joint space; vast osteophytes are formed; severe osteosclerosis under the cartilage; bone hypertrophy and evident deformity
Key exclusion criteria (1 listed)
- Subsequent arthritis (including rheumatoid arthritis, Gouty arthritis, traumatic arthritis, etc.) were excluded.
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 |
|---|---|---|
| iced normal salineAlso: H19983149Iced normal saline (20ml) was given intraoperative joint cavity infusion therapy | Drug | Group A, Group B |
| Tranexamic acid injectionAlso: H4302056520ml of tranexamic was given with iced normal saline for intraoperative joint cavity infusion. | Drug | Control group, Group A, Group B |
| Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusionCocktail was formulated during the operation by mixing Ropivacaine 150mg, Morphine 10mg and Epinephrine 1mg, then normal saline was used to dilute the mixture to 60ml. Then the cocktail mixture was applied for the joint cavity perfusion. | Other | Group B |
Primary outcome
Reduced pain
Time frame: three days after operation
the pain after operation reduced significantly.
1 secondary outcome
Reduced bleeding
Time frame: 24 hours drainage.
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 24 Jan 2022.
- 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. This study is not recruiting at the moment.
Laijian Sui, Doctor study chair
Yantai Yuhuangding Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iced normal saline, Tranexamic acid injection and Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusion in people with Pain, Postoperative and Blood Loss, Postoperative, run by Yantai Yuhuangding 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 1 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 24 Jan 2022. 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.
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?
Reduced pain (time frame: three days after operation). 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 24 Jan 2022.