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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-12-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Total Knee ArthroplastyKnee Pain, Functionality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

This study was designed as blinded, randomized and controlled.the person who evaluates the patients before and after the treatment is blind.In other words,the person evaluating the patients and the person giving the treatment are different.

Study Groups

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PCI + ACB Group

Firstly, 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.For the adductor canal block, which will be applied by the anesthesiologist at the end of the operation, first of all, the femoral artery and nerve in the inguinal region are visualized while the patient is in the supine position, accompanied by ultrasonography. 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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

IPACK block + ACB Group

First of all, for the adductor canal block, which will be applied by the anesthesiologist at the end of the operation, the femoral artery and nerve in the inguinal region are visualized by ultrasonography while the patient is in the supine position. Afterwards, the artery is followed distally and the adductor canal and the femoral arter 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. then ACB is performed with the help of USG in the anatomical space between the posterior capsule and the popliteal artery. In practice, a 22G 10 cm needle is used in the form of 20 ml 0.25% bupivacaine + 2.0 μg/mL of epinephrine.

Group Type EXPERIMENTAL

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

Intervention Type 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)

Intervention Type 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.

ACB Group (control)

At the end of the operation by the anesthesiologist only adductor canal block is applied, while the patient is in the supine position, the femoral artery and nerve are visualized in the inguinal region under ultrasound guidance. 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. Hours -48th hour and 72nd hour.

Group Type OTHER

ACB ( 0.25% marcaine + %0.9 saline)

Intervention Type 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.

Interventions

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

ACB ( 0.25% marcaine + %0.9 saline)

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No