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Completed

NCT Number: NCT05943080

Comparison of IPACK Block and PCI for Postoperative Analgesia and Function Recovery Following Total Knee Arthroplasty

It was planned to determine the most effective single and/or combined use in daily use by evaluating the effect on pain control and functional status by combining the posterior capsuler infiltration (PCI) and interspace between the popliteal artery and the capsule of the posterior knee(IPACK block) performed during total knee replacement surgery with the adductor canal block method.

In the randomized controlled study:

Group 1; By determining the anatomical landmarks to be applied by the intraoperative surgeon, PCI + Adductor canal block (ACB) without any additional imaging, Group 2; IPACK+ACB applied by the anesthesiologist with the help of post-operative USG, In Group 3, there are 3 groups in which only ACB application is made. VAS values and opioid consumption of the groups will be recorded as the primary outcome after the surgery.

As a secondary outcome, the 1st day rehabilitation initiation times and endurance of the patients With 1.2. and on Day 3 joint ranges of motion will be recorded.

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Key information

Conditions

Total Knee ArthroplastyKnee Pain, Functionality

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahievran university

Kirşehi̇r, 40100, Turkey (Türkiye)

About this study

Patients with end-stage knee osteoarthritis who were examined in our study institution and who could not respond to conservative treatment and who accepted total knee replacement (TDP) surgery will be included.

Patients will be divided into three groups by randomization: Preoperative range of motion and pain scores (VAS) of the patients will be recorded in the service examination room. By determining the anatomical landmarks to be applied by the intraoperative surgeon, they will be asked to choose one of the 3 groups in which PCI + ACB , group 2; ACB + IPACK applied by the anesthesiologist with the help of Post-operative USg, and group 3, in which only ACB application will be made, and this choice will not be known by the patient.

PCI; Perioperative application is performed in the anatomical space between the posterior capsule and the popliteal artery before implantation. In the application, a 22G 10 cm needle is used in the form of 20 ml 0.25% bupivacaine + 2.0 μg/mL of epinephrine.

IPACK: Following the closure of the wound in the postoperative period, the application is made into the anatomical space between the posterior capsule and the popliteal artery with the help of USG. In the application, 20 ml 0.25% bupivacaine + 2.0 μg/mL of epinephrine is used with a 22G 10 cm needle.

ACB: For the adductor canal block, which will be applied by the anesthesiologist at the end of the operation, the femoral artery and nerve are visualized in the inguinal region with ultrasonography while the patient is in the supine position. Afterwards, the artery is followed distally and the adductor canal and the femoralarter inside it and the nerve are visualized. At the level just below the sartorius muscle, a simultaneous needle is visualized by ultrasonography and 7m of 0.5%bupivacaine + 8ml of 0.9% saline solution is injected into the adductor canal. Appropriate drug distribution is confirmed by ultrasonography and the procedure is terminated.

VAS values and opioid consumption will be recorded as the primary outcome of the patients who are taken to the service after the surgical procedure performed under spinal anesthesia without the use of a tourniquet. Post-operative 3. Hour-12. Hour -24. Hour -48th hour and 72th hour VAS will be recorded. The total opioid consumption on the 1st, 2nd and 3rd days, when the patient needs analgesics (opioids) in the first postoperative hour will be noted.

As the Secondary Outcome, the patients' 1st day rehabilitation initiation times and their endurance are measured in 1.2. and on Day 3 joint ranges of motion will be recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Performing total knee joint arthroplasty due to stage 4 gonarthrosis Agree to participate in the study Having signed the informed consent form

Exclusion criteria

  • Presence of malignancy, infection, rheumatological disease Same side has had previous surgery Known psychiatric and/or neurological diseases Expenses due to any medication or substance use

Treatment and study plan

PCI (0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline)

Drug

The application is made into the anatomical space between the posterior capsule and the popliteal artery before implantation.

IPACK(0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline)

Drug

It is applied to the anatomical space between the posterior capsule and the popliteal artery with the help of USG.

ACB ( 0.25% marcaine + %0.9 saline)

Drug

It is inserted into the adductor canal by simultaneous imaging of the needle, accompanied by ultrasonography, from the level just below the sartorius muscle.

Primary outcomes

  1. Pain Intensity

    Time frame: [Time Frame: 1 day before surgery]

    Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.

  2. Pain Intensity

    Time frame: [Time Frame: 3th hour after surgery]

    Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.

  3. Pain Intensity

    Time frame: [Time Frame: 8th hour after surgery]

    Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.

  4. Pain Intensity

    Time frame: [Time Frame: 12th hour after surgery]

    Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.

  5. Pain Intensity

    Time frame: [Time Frame: 24th hour after surgery]

    Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.

  6. Pain Intensity

    Time frame: [Time Frame: 48th hour after surgery]

    Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.

  7. Pain Intensity

    Time frame: [Time Frame: 72th hour after surgery]

    Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.

  8. opioid usage

    Time frame: first hour of use

    usage vanalgesics (opioids) in the first postoperative hour

  9. opioid comsuption

    Time frame: [Time Frame: 24th hour after surgery]

    opioid consumption after surgery

  10. opioid comsuption

    Time frame: [Time Frame: 48th hour after surgery]

    opioid consumption after surgery

  11. opioid comsuption

    Time frame: [Time Frame: 72th hour after surgery]

    opioid consumption after surgery

Secondary outcomes

  1. Measuring knee Joint Range of Motion

    Time frame: [Time Frame: 1 day before surgery]

    Knee joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, knee ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.

  2. Measuring knee Joint Range of Motion

    Time frame: [Time Frame: 1 days after before surgery]

    Knee joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, knee ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.

  3. Measuring knee Joint Range of Motion

    Time frame: [Time Frame: 3 days after surgery]

    Knee joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, knee ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.

  4. Measuring knee Joint Range of Motion

    Time frame: [Time Frame: 10 days after surgery]

    Knee joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, knee ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Registry information

Official study title

Comparison of Adductor Canal Block Combined With IPACK Block and Adductor Canal Block Combined With PCI for Postoperative Analgesia and Function Recovery Following Total Knee Arthroplasty:A Prospective, Double-Blind, Randomized Controlled Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2023
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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