Comparison of Local Anesthetic Dose in Ipack Block Performed in Knee Arthroplasty Operations

NCT05963139 | Completed

• 1 other identifier: 2022-1481345
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators research was designed as a single-center, prospective, randomized study. The patients undergoing knee artrhroplasty surgery in Istanbul University Istanbul Medicine Faculty Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will not be included in the study. Patients will be given US guided IPACK and adductor blocks using a 22 gauge 10 mm block needle after compliance with the rules of asepsia and antisepsis in the supine position according to the group of patients in which they were included. IPACK and adductor block will be done for postoperative analgesia. After then, a single dose of spinal anesthesia will be applied as a regional anesthesia method, in a sitting position, using the appropriate spinal needle, as is routinely applied in the investigators clinic. After the block is completed, the pinprick test will be done and the operation will be started after the successful completion of the block is confirmed. Oxygen will be given to the patients with a face mask at 4 lt / min throughout the operation. ECG, saturation, invasive / noninvasive blood pressure monitoring of the patients will be done. In the investigators clinic, the use of IPACK block, adductor block and PCA (patient controlled analgesia) device with intravenous morphine for postoperative analgesia is routinely performed. In this study, four randomized groups will be formed together with the control group. IPACK block will be applied to the 1st group with 10 ml of 0.25% bupivacaine, to the 2nd group with 15 ml of 0.25% bupivacaine, and to the 3rd group with 20 ml of 0.25% bupivacaine.Adductor block will be applied to all the groups with 15 ml %0,25 bupivacaine and PCA (patient controlled analgesia) device with intravenous morphine for postoperative analgesia is performed. Pain score and total morphine consumption will be determined by numeric rating scale (NRS) at the postoperative 1, 4, 8, 12, 24 and 48th hours by providing the use of a PCA device with intravenous morphine applied in routine practice to all four groups. As in routine practice, when NRS \> 4 after each interrogation, morphine 2 mg iv will be administered as additional analgesia and the maximum will be increased to 10 mg. Pain management will continue when NRS \< 4.

Conditions

Analgesia; Pain, Postoperative; Anesthesia

Keywords

IPACK block; Postoperative Pain; Postoperative Patient Controlled Analgesia; Knee Artroplasty; Regional Anesthesia; Numeric rating scale

Outcome Measures

Primary Outcomes (2)

• Numeric Rating Scale(0-10)pain scores for patients.

  NRS(Numeric Rating Scale),0:no pain,10:the worst pain.

  postoperative period up to 48 hours

• Opioid (mg) consumption

  Opioid (mg) consumption

  postoperative period up to 48th hours

Secondary Outcomes (8)

• Incidence of side effects

  postoperative period up to 48th hours

• Time until postoperative first mobilization

  Up to 48 hours

• Length of hospital stay

  Through study completion, an average of 1 week.

• Womac osteoarthritis index

  Discharge 1 day from the hospital

• The Medical Research Council (MRC) Scale for Muscle Strength for lower extremity

  Discharge 1 day from the hospital

Study Arms (4)

Group 1:10 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block

ACTIVE COMPARATOR

In this group,US guided IPACK block will be performed with 10 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle.

Drug: Bupivacaine; Drug: Morphine Sulfate

Group 2:15 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block

ACTIVE COMPARATOR

In this group,US guided IPACK block will be performed with 15 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle.

Drug: Bupivacaine; Drug: Morphine Sulfate

Group 3:20 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block

ACTIVE COMPARATOR

In this group,US guided IPACK block will be performed with 20 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle.

Drug: Bupivacaine; Drug: Morphine Sulfate

Group 4:15 ml %0,25 bupivacaine adductor block and intravenous patient controlled analgesia

ACTIVE COMPARATOR

In this group adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle and postoperative patient controlled analgesia with morphine will be preferred for postoperative analgesia method.

Drug: Bupivacaine; Drug: Morphine Sulfate

Interventions

Bupivacaine DRUG

US guided IPACK block will be performed with 10/15/20 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0,25 bupivacaine.

Also known as: Marcaine

Group 1:10 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block; Group 2:15 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block; Group 3:20 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block; Group 4:15 ml %0,25 bupivacaine adductor block and intravenous patient controlled analgesia

Morphine Sulfate DRUG

In this group,adductor block will be performed with 15 ml %0,25 bupivacaine using a 22 gauge 10 mm block needle and patients will be postoperatively administered patient controlled analgesia with morphine.

Also known as: morphine

Group 1:10 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block; Group 2:15 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block; Group 3:20 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block; Group 4:15 ml %0,25 bupivacaine adductor block and intravenous patient controlled analgesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for knee arthroplasty surgery under regional anesthesia
• ASA(American Society of Anesthesiology) 1-3
• Receiving consent that accept regional analgesia

You may not qualify if:

• Refusal of regional anesthesia
• Infection on the local anesthetic application area
• Infection in the central nervous system
• Coagulopathy
• BMI \> 40
• Known allergy against local anesthetics

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Medical Faculty

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• Zheng FY, Liu YB, Huang H, Xu S, Ma XJ, Liu YZ, Chu HC. The impact of IPACK combined with adductor canal block under ultrasound guidance on early motor function after total knee arthroplasty. Braz J Anesthesiol. 2022 Jan-Feb;72(1):110-114. doi: 10.1016/j.bjane.2021.04.012. Epub 2021 Apr 26.

  PMID: 33915199 BACKGROUND

• Kim DH, Beathe JC, Lin Y, YaDeau JT, Maalouf DB, Goytizolo E, Garnett C, Ranawat AS, Su EP, Mayman DJ, Memtsoudis SG. Addition of Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee and Adductor Canal Block to Periarticular Injection Enhances Postoperative Pain Control in Total Knee Arthroplasty: A Randomized Controlled Trial. Anesth Analg. 2019 Aug;129(2):526-535. doi: 10.1213/ANE.0000000000003794.

  PMID: 30234517 BACKGROUND

• Patterson ME, Vitter J, Bland K, Nossaman BD, Thomas LC, Chimento GF. The Effect of the IPACK Block on Pain After Primary TKA: A Double-Blinded, Prospective, Randomized Trial. J Arthroplasty. 2020 Jun;35(6S):S173-S177. doi: 10.1016/j.arth.2020.01.014. Epub 2020 Jan 15.

  PMID: 32005622 BACKGROUND

• D'Souza RS, Langford BJ, Olsen DA, Johnson RL. Ultrasound-Guided Local Anesthetic Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee (IPACK) Block for Primary Total Knee Arthroplasty: A Systematic Review of Randomized Controlled Trials. Local Reg Anesth. 2021 May 12;14:85-98. doi: 10.2147/LRA.S303827. eCollection 2021.

  PMID: 34012290 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Bupivacaine; Morphine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• GÜLBERK KILIÇ, MD

  Istanbul Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, M.D.

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 27, 2023
• Study Start: August 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 10, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

TU (1)