Knee InjuriesNCT05751109
Comparison of IPACK and Adductor Canal Block Combination Versus Epidural Analgesia for Total Knee Arthroplasty
An observational study of Knee Injuries, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 2 sites in Turkey (Türkiye).
Trial summary
To compare the efficacy and complications of IPACK and adductor canal block combination and epidural block in patients who will be operated for knee arthroscopy under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Injuries
- What is being tested?
- ipack+adduktor kanal
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Oct 2023
- How long will I take part?
- 9 Months
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 80 people
Who may be able to join
- Those who consented to participate in the study
- Patients over the age of 18 who will be operated on due to knee pathology
- Patients to be operated under spinal anesthesia
- Disease that will limit cooperation
Who cannot join
- Patients under the age of 18
- Patients to be operated under general anesthesia
- Disease that will cause limited cooperation
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Onur Karaoglu
Istanbul, Kağıthane, 34400
Rasim Onur Karaoglu
Istanbul, Kağıthane, 34400
About this study
Official title: Comparison of Infiltration Between the Popliteal Artery and the Capsule of the Knee (IPACK) Block and Adductor Canal Block Combination Versus Epidural Analgesia for Total Knee Arthroplasty
To compare the efficacy and complications of IPACK and adductor canal block combination and epidural block in patients who will be operated for knee arthroscopy under spinal anesthesia.
Read the detailed description
Between 15.08.2022 and 15.04.2023, the patients who will be operated on for knee surgery under spinal anesthesia, older than 18 years of age were included in the study. Demographic characteristics of the patients, comorbidities, ASA scores, mobilization time, amount of postoperative analgesic use, and postoperative pain scores of the 1. 8. 24. hours will be observed. The vas score at the 3rd month was learned over the phone.
- Conditions
- Knee Injuries
- Being tested
- ipack+adduktor kanal
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ipack+adduktor kanalProcedure or surgery
Also called kombine epidural
nerve block
| Study group | Role | What they receive |
|---|---|---|
| ipack+adductor canal block | The 40 patients received ACB + IPACK (Group 1, n = 40),. All patients were evaluated with VAS score for pain recorded at 1h, 8 h, postoperative day (POD) 1 and 3. month after the surgery. The secondary outcome measures assessed were movement time and discharge time. Receives: Procedure: ipack+adduktor kanal | |
| epidural analgesia | The 40 patients received combine spinal epidural (Group 2, n = 40),. All patients were evaluated with VAS score for pain recorded at 1h, 8 h, postoperative day (POD) 1 and 3. month after the surgery. The secondary outcome measures assessed were movement time and discharge time. Receives: Procedure: ipack+adduktor kanal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) evaluation for postoperative pain
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: 8. Hour
Secondary outcomes (2)
Visual Analogue Scale (VAS) evaluation for postoperative pain
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: 1. Hour
Visual Analogue Scale (VAS) evaluation for postoperative pain
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: 24. Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Aug 2022
- Primary completion16 Aug 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasim Onur Karaoglu, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751109
- Sponsor's protocol ID
- 681423
- Status last verified
- Jan 2024
- First submitted
- 22 Sep 2022
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Infiltration Between the Popliteal Artery and the Capsule of the Knee (IPACK) Block and Adductor Canal Block Combination Versus Epidural Analgesia for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05751109
- Acronym / sponsor ID
- 681423
- Conditions
- Knee Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 2 Mar 2023 (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.
To compare the efficacy and complications of IPACK and adductor canal block combination and epidural block in patients who will be operated for knee arthroscopy under spinal anesthesia.
Detailed description
Between 15.08.2022 and 15.04.2023, the patients who will be operated on for knee surgery under spinal anesthesia, older than 18 years of age were included in the study. Demographic characteristics of the patients, comorbidities, ASA scores, mobilization time, amount of postoperative analgesic use, and postoperative pain scores of the 1. 8. 24. hours will be observed. The vas score at the 3rd month was learned over the phone.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ipack+adductor canal block | – | Procedure: ipack+adduktor kanalThe 40 patients received ACB + IPACK (Group 1, n = 40),. All patients were evaluated with VAS score for pain recorded at 1h, 8 h, postoperative day (POD) 1 and 3. month after the surgery. The secondary outcome measures assessed were movement time and discharge time. |
| epidural analgesia | – | Procedure: ipack+adduktor kanalThe 40 patients received combine spinal epidural (Group 2, n = 40),. All patients were evaluated with VAS score for pain recorded at 1h, 8 h, postoperative day (POD) 1 and 3. month after the surgery. The secondary outcome measures assessed were movement time and discharge time. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 80 people
Key inclusion criteria (4 listed)
- Those who consented to participate in the study
- Patients over the age of 18 who will be operated on due to knee pathology
- Patients to be operated under spinal anesthesia
- Disease that will limit cooperation
Key exclusion criteria (3 listed)
- Patients under the age of 18
- Patients to be operated under general anesthesia
- Disease that will cause limited cooperation
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 |
|---|---|---|
| ipack+adduktor kanalAlso: kombine epiduralnerve block | Procedure or surgery | epidural analgesia, ipack+adductor canal block |
Primary outcome
Visual Analogue Scale (VAS) evaluation for postoperative pain
Time frame: 8. Hour
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
2 secondary outcomes
Visual Analogue Scale (VAS) evaluation for postoperative pain
Time frame: 1. Hour
Visual Analogue Scale (VAS) evaluation for postoperative pain
Time frame: 24. Hour
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 3 Jan 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Injuries, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 2 sites in Turkey (Türkiye).
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 4 inclusion and 3 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Visual Analogue Scale (VAS) evaluation for postoperative pain (time frame: 8. Hour). 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 3 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.