Knee OsteoarthritisNCT04603950
IPICK Blocking for TKA With Moderate Flexion Contracture
A study testing CACB+IPACK and CACB in people with Knee Osteoarthritis and Flexion Contracture of Knees, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
Clinical effect of intermittent multiple IPICK blocking on TKA for knee osteoarthritis with flexion contracture between 5 ° and 10 ° Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Flexion Contracture of Knees, Anesthesia, Local
- What is being tested?
- CACB+IPACK and CACB
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 31 Mar 2021
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis was knee osteoarthritis
- The flexion contracture was between 5 and 10 degrees
- ASA grade I-III
Who cannot join
- Lower extremity neuropathy.
- Contraindications of nerve anesthesia or regional anesthesia.
- unable to cooperate, allergic to the drugs used in this study.
- Non steroidal anti-inflammatory drugs are not tolerated.
- chronic opioid consumption (daily or almost daily use)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IPICK Blocking for Extension Recovery in TKA With Preoperative Moderate Flexion Contracture
Clinical effect of intermittent multiple IPICK blocking on TKA for knee osteoarthritis with flexion contracture between 5 ° and 10 °
Read the detailed description
From October 2020 to January 2021, 40 knee osteoarthritis patients with flexion contracture between 5 ° and 10 ° total knee arthroplasty are enrolled in this study. 20 patients are treated with Adductor Canal Block + Infiltration between the Popliteal Artery and Capsule of the Knee, and 20 patients are treated with Adductor Canal Block alone.
- Being tested
- CACB+IPACK, CACB
- Keywords
- IPACK, knee osteoarthritis, Flexion Contracture of Knees
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CACB+IPACKProcedure or surgery
continue adductor canal block plus Infiltration between the Popliteal Artery and Capsule of the Knee
CACBProcedure or surgery
continue adductor canal block
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | The first 20 patients received Continue Adductor Canal Block + Infiltration between the Popliteal Artery and Capsule of the Knee Receives: Procedure: CACB+IPACK |
| control group | Sham comparator | The second 20 patients received Continue Adductor Canal Block alone Receives: Procedure: CACB |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of pain
Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.
Measured: 6 hours after surgery
evaluation of pain
Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.
Measured: postoperative day 1
evaluation of pain
Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.
Measured: postoperative day 2
evaluation of pain
Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.
Measured: postoperative day 3
extension angle
degree of the extension of knee
Measured: before surgery
extension angle
degree of the extension of knee
Measured: 0 hour after surgery
extension angle
degree of the extension of knee
Measured: 6 hour after surgery
extension angle
degree of the extension of knee
Measured: postoperative day 1
extension angle
degree of the extension of knee
Measured: postoperative day 2
extension angle
degree of the extension of knee
Measured: postoperative day 3
Secondary outcomes (7)
range of motion
degree of range of motion from extension to flexion of knee
Measured: 6 hour after surgery
range of motion
degree of range of motion from extension to flexion of knee
Measured: postoperative day 1
range of motion
degree of range of motion from extension to flexion of knee
Measured: postoperative day 2
range of motion
degree of range of motion from extension to flexion of knee
Measured: postoperative day 3
opioid consumption
total opioid consumption measured by milliliter.
Measured: through hospitalization, an average of 7 days
nerve block related symptoms
the incidence of numbness of the nerve related skin
Measured: through hospitalization, an average of 7 days
postoperative acute pain
number of cases whose Visual Analog Score for pain was more than 5
Measured: through hospitalization, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Nov 2020
- Primary completion28 Feb 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603950
- Sponsor's protocol ID
- QiXin2
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2020
- Last updated
- 26 Jul 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 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IPICK Blocking for Extension Recovery in TKA With Preoperative Moderate Flexion Contracture
- ClinicalTrials.gov ID
- NCT04603950
- Acronym / sponsor ID
- QiXin2
- Keywords
- IPACK, knee osteoarthritis, Flexion Contracture of Knees
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 27 Oct 2020 (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.
Clinical effect of intermittent multiple IPICK blocking on TKA for knee osteoarthritis with flexion contracture between 5 ° and 10 °
Detailed description
From October 2020 to January 2021, 40 knee osteoarthritis patients with flexion contracture between 5 ° and 10 ° total knee arthroplasty are enrolled in this study. 20 patients are treated with Adductor Canal Block + Infiltration between the Popliteal Artery and Capsule of the Knee, and 20 patients are treated with Adductor Canal Block alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: CACB+IPACKThe first 20 patients received Continue Adductor Canal Block + Infiltration between the Popliteal Artery and Capsule of the Knee |
| control group | Sham comparator | Procedure: CACBThe second 20 patients received Continue Adductor Canal Block alone |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The diagnosis was knee osteoarthritis
- The flexion contracture was between 5 and 10 degrees
- ASA grade I-III
Key exclusion criteria (5 listed)
- Lower extremity neuropathy.
- Contraindications of nerve anesthesia or regional anesthesia.
- unable to cooperate, allergic to the drugs used in this study.
- Non steroidal anti-inflammatory drugs are not tolerated.
- chronic opioid consumption (daily or almost daily use)
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 |
|---|---|---|
| CACB+IPACKcontinue adductor canal block plus Infiltration between the Popliteal Artery and Capsule of the Knee | Procedure or surgery | study group |
| CACBcontinue adductor canal block | Procedure or surgery | control group |
Primary outcome
evaluation of pain
Time frame: 6 hours after surgery
Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.
evaluation of pain
Time frame: postoperative day 1
Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.
evaluation of pain
Time frame: postoperative day 2
Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.
evaluation of pain
Time frame: postoperative day 3
Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.
extension angle
Time frame: before surgery
degree of the extension of knee
extension angle
Time frame: 0 hour after surgery
degree of the extension of knee
extension angle
Time frame: 6 hour after surgery
degree of the extension of knee
extension angle
Time frame: postoperative day 1
degree of the extension of knee
extension angle
Time frame: postoperative day 2
degree of the extension of knee
extension angle
Time frame: postoperative day 3
degree of the extension of knee
7 secondary outcomes
range of motion
Time frame: 6 hour after surgery
range of motion
Time frame: postoperative day 1
range of motion
Time frame: postoperative day 2
range of motion
Time frame: postoperative day 3
opioid consumption
Time frame: through hospitalization, an average of 7 days
nerve block related symptoms
Time frame: through hospitalization, an average of 7 days
postoperative acute pain
Time frame: through hospitalization, an average of 7 days
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 26 Jul 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.
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 study testing CACB+IPACK and CACB in people with Knee Osteoarthritis and Flexion Contracture of Knees, run by The First Hospital of Jilin University 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 5 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 26 Jul 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. 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.
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?
evaluation of pain (time frame: 6 hours after surgery). The study lists 10 primary outcomes in all. 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 26 Jul 2022.