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

NCT05943080 | Completed

• 1 other identifier: 2023-12/86
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee ArthroplastyKnee Pain, Functionality

Keywords

Total Knee Arthroplasty,Knee Pain, Functionality after tka, Posterior knee analgesia

Outcome Measures

Primary Outcomes (11)

• Pain Intensity

  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.

  [Time Frame: 1 day before surgery]

• Pain Intensity

  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.

  [Time Frame: 3th hour after surgery]

• Pain Intensity

  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.

  [Time Frame: 8th hour after surgery]

• Pain Intensity

  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.

  [Time Frame: 12th hour after surgery]

• Pain Intensity

  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.

  [Time Frame: 24th hour after surgery]

• Pain Intensity

  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.

  [Time Frame: 48th hour after surgery]

• Pain Intensity

  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.

  [Time Frame: 72th hour after surgery]

• opioid usage

  usage vanalgesics (opioids) in the first postoperative hour

  first hour of use

• opioid comsuption

  opioid consumption after surgery

  [Time Frame: 24th hour after surgery]

• opioid comsuption

  opioid consumption after surgery

  [Time Frame: 48th hour after surgery]

• opioid comsuption

  opioid consumption after surgery

  [Time Frame: 72th hour after surgery]

Secondary Outcomes (4)

• Measuring knee Joint Range of Motion

  [Time Frame: 1 day before surgery]

• Measuring knee Joint Range of Motion

  [Time Frame: 1 days after before surgery]

• Measuring knee Joint Range of Motion

  [Time Frame: 3 days after surgery]

• Measuring knee Joint Range of Motion

  [Time Frame: 10 days after surgery]

Study Arms (3)

PCI + ACB Group

EXPERIMENTAL

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.

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

IPACK block + ACB Group

EXPERIMENTAL

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.

Drug: IPACK(0.25% marcaine+ 2.0 μg/mL of adrenaline + %0.9 saline); Drug: ACB ( 0.25% marcaine + %0.9 saline)

ACB Group (control)

OTHER

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.

Drug: ACB ( 0.25% marcaine + %0.9 saline)

Interventions

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.

PCI + ACB Group

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.

IPACK block + ACB Group

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.

ACB Group (control); IPACK block + ACB Group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Ahievran university

Kirşehi̇r, 40100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 22357571 BACKGROUND

• 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.

  PMID: 30232819 RESULT

• 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.

  PMID: 29721648 RESULT

MeSH Terms

Interventions

Bupivacaine; Epinephrine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant proffesor

Model Details: randomized controlled study

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 13, 2023
• Study Start: June 1, 2023
• Primary Completion: August 10, 2023
• Study Completion: December 15, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)