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Comparison of IPACK and Adductor Canal Block Combination Versus Epidural Analgesia for Total Knee Arthroplasty

Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization (Other)
Overall Status
Recruiting
CT.gov ID
NCT05751109
Collaborator
(none)
80
Enrollment
2
Locations
9
Anticipated Duration (Months)
40
Patients Per Site
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ipack+adduktor kanal

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm 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.

Procedure: ipack+adduktor kanal
nerve block
Other Names:
  • kombine epidural

    		•
    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.

    Procedure: ipack+adduktor kanal
    nerve block
    Other Names:
  • kombine epidural

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual Analogue Scale (VAS) evaluation for postoperative pain [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').

    Secondary Outcome Measures

    1. Visual Analogue Scale (VAS) evaluation for postoperative pain [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').

    2. Visual Analogue Scale (VAS) evaluation for postoperative pain [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').

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Onur Karaoglu Istanbul Kağıthane Turkey 34400
    2 Rasim Onur Karaoglu İstanbul Kağıthane Turkey 34400

    Sponsors and Collaborators

    • Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rasim Onur Karaoglu, Principal Investigator, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
    ClinicalTrials.gov Identifier:
    NCT05751109
    Other Study ID Numbers:
    • 681423
    First Posted:
    Mar 2, 2023
    Last Update Posted:
    Mar 2, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Knee Injuries

    Study Results

    No Results Posted as of Mar 2, 2023