Clinical trial NCT05943080: Comparison of IPACK Block and PCI for Postoperative Analgesia and Function Recovery Following Total Knee Arthroplasty
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee ArthroplastyKnee Pain, Functionality
Keywords: Total Knee Arthroplasty,Knee Pain, Functionality after tka, Posterior knee analgesia
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 195
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity
timeFrame: [Time Frame: 1 day before surgery]
measure: Pain Intensity
timeFrame: [Time Frame: 3th hour after surgery]
measure: Pain Intensity
timeFrame: [Time Frame: 8th hour after surgery]
measure: Pain Intensity
timeFrame: [Time Frame: 12th hour after surgery]
measure: Pain Intensity
timeFrame: [Time Frame: 24th hour after surgery]
measure: Pain Intensity
timeFrame: [Time Frame: 48th hour after surgery]
measure: Pain Intensity
timeFrame: [Time Frame: 72th hour after surgery]
measure: opioid usage
timeFrame: first hour of use
measure: opioid comsuption
timeFrame: [Time Frame: 24th hour after surgery]
measure: opioid comsuption
timeFrame: [Time Frame: 48th hour after surgery]
measure: opioid comsuption
timeFrame: [Time Frame: 72th hour after surgery]
Secondary outcomes:
measure: Measuring knee Joint Range of Motion
timeFrame: [Time Frame: 1 day before surgery]
measure: Measuring knee Joint Range of Motion
timeFrame: [Time Frame: 1 days after before surgery]
measure: Measuring knee Joint Range of Motion
timeFrame: [Time Frame: 3 days after surgery]
measure: Measuring knee Joint Range of Motion
timeFrame: [Time Frame: 10 days after surgery]
Other outcomes:
Locations:
city: Kirşehi̇r
country: Turkey
facility: Ahievran university
Study officials:
References:
citation: Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012.
citation: Niesen AD, Harris DJ, Johnson CS, Stoike DE, Smith HM, Jacob AK, Amundson AW, Pawlina W, Martin DP. Interspace between Popliteal Artery and posterior Capsule of the Knee (IPACK) Injectate Spread: A Cadaver Study. J Ultrasound Med. 2019 Mar;38(3):741-745. doi: 10.1002/jum.14761. Epub 2018 Sep 19.
citation: Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.