- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05751109
Comparison of IPACK and Adductor Canal Block Combination Versus Epidural Analgesia for Total Knee Arthroplasty
January 2, 2024 updated by: Rasim Onur Karaoglu, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kağıthane
-
Istanbul, Kağıthane, Turkey, 34400
- Onur Karaoglu
-
İstanbul, Kağıthane, Turkey, 34400
- Rasim Onur Karaoglu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
80 people
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients under the age of 18
- Patients to be operated under general anesthesia
- Disease that will cause limited cooperation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
nerve block
Other Names:
|
|
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.
|
nerve block
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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').
|
8. Hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale (VAS) evaluation for postoperative pain
Time Frame: 1. 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').
|
1. Hour
|
|
Visual Analogue Scale (VAS) evaluation for postoperative pain
Time Frame: 24. 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').
|
24. Hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2022
Primary Completion (Actual)
August 16, 2023
Study Completion (Actual)
October 1, 2023
Study Registration Dates
First Submitted
September 22, 2022
First Submitted That Met QC Criteria
March 1, 2023
First Posted (Actual)
March 2, 2023
Study Record Updates
Last Update Posted (Estimated)
January 3, 2024
Last Update Submitted That Met QC Criteria
January 2, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 681423
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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