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

Primary Purpose

Analgesia, Pain, Postoperative, Anesthesia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine
Morphine Sulfate
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Analgesia focused on measuring IPACK block, Postoperative Pain, Postoperative Patient Controlled Analgesia, Knee Artroplasty, Regional Anesthesia, Numeric rating scale

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University Istanbul Medical FacultyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

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

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Numeric Rating Scale(0-10)pain scores for patients.
NRS(Numeric Rating Scale),0:no pain,10:the worst pain.
Opioid (mg) consumption
Opioid (mg) consumption

Secondary Outcome Measures

Incidence of side effects
Incidence of nausea and vomiting
Time until postoperative first mobilization
First mobilization time
Length of hospital stay
Hospitalization
Womac osteoarthritis index
Womac osteoarthritis index
The Medical Research Council (MRC) Scale for Muscle Strength for lower extremity
The Medical Research Council (MRC) Scale for Muscle Strength is a commonly used scale for assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction).
Joint range of motion
Joint range of motion
Patient satisfaction
Satisfaction score;0-very unsatisfied,5-very satisfied.
Surgeon satisfaction
Satisfaction score;0-very unsatisfied,5-very satisfied.

Full Information

First Posted
July 19, 2023
Last Updated
August 1, 2023
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05963139
Brief Title
Comparison of Local Anesthetic Dose in Ipack Block Performed in Knee Arthroplasty Operations
Official Title
Comparison of Local Anesthetic Dose in IPACK (Interspace Between the Popliteal Artery and the Posterior Capsule of the Knee) Block Performed for Postoperative Analgesia in Knee Artroplasty Operations
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The investigators research was designed as a single-center, prospective, randomized study. The patients undergoing knee arthroplasty 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 evaluated preoperative before surgery, a detailed history will be taken and physical examination will be carried out. Medical and surgical resume information will be obtained. Patients' NRS scores will be recorded before the operation. Patients will be taken to the operating room after premedication. ECG, pulse oximeter, blood pressure monitoring will be performed in the operating room. 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.Computer-generated random numbers will be used for simple randomization of patients. 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. Patients are followed up in the service for 48 hours postoperatively in routine practice. In the postoperative period, patients will be evaluated in terms of additional nausea and vomiting,amount of morphine consumed and additional analgesic need postoperative period up to 48 hours.First mobilization time, hospitalization time will be evaluated.Womac osteoarthritis index and joint range of motion will be evaluated at preoperative period and at the discharge day from the hospital.The Medical Research Council (MRC) Scale for Muscle Strength for lower extremity will be evaluated preoperative period, at postoperative 24th hour and at the discharge day from the hospital. Postop patient satisfaction and surgical satisfaction with Likert scale will also be evaluated at postoperative period. During the procedure, complications such as failed block, nerve damage, vascular injury, intravenous injection of local anesthetic, local anesthetic toxicity and allergic reactions will be recorded. Before the study, it was determined that at least 112 patients should be collected in the power analysis performed with the help of similar literature data. After collecting the demographic data and morphine consumption data of the patients, the data will be transferred to the statistical program called SPSS and statistical analysis will be made.The investigators study does not contain any modifications other than the investigators daily routine practices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Pain, Postoperative, Anesthesia
Keywords
IPACK block, Postoperative Pain, Postoperative Patient Controlled Analgesia, Knee Artroplasty, Regional Anesthesia, Numeric rating scale

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1:10 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2:15 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 3:20 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 4:15 ml %0,25 bupivacaine adductor block and intravenous patient controlled analgesia
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Morphine Sulfate
Other Intervention Name(s)
morphine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Rating Scale(0-10)pain scores for patients.
Description
NRS(Numeric Rating Scale),0:no pain,10:the worst pain.
Time Frame
postoperative period up to 48 hours
Title
Opioid (mg) consumption
Description
Opioid (mg) consumption
Time Frame
postoperative period up to 48th hours
Secondary Outcome Measure Information:
Title
Incidence of side effects
Description
Incidence of nausea and vomiting
Time Frame
postoperative period up to 48th hours
Title
Time until postoperative first mobilization
Description
First mobilization time
Time Frame
Up to 48 hours
Title
Length of hospital stay
Description
Hospitalization
Time Frame
Through study completion, an average of 1 week.
Title
Womac osteoarthritis index
Description
Womac osteoarthritis index
Time Frame
Discharge 1 day from the hospital
Title
The Medical Research Council (MRC) Scale for Muscle Strength for lower extremity
Description
The Medical Research Council (MRC) Scale for Muscle Strength is a commonly used scale for assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction).
Time Frame
Discharge 1 day from the hospital
Title
Joint range of motion
Description
Joint range of motion
Time Frame
Postoperative period up to 48th hours, discharge 1 day
Title
Patient satisfaction
Description
Satisfaction score;0-very unsatisfied,5-very satisfied.
Time Frame
Postoperative period up to 48th hours
Title
Surgeon satisfaction
Description
Satisfaction score;0-very unsatisfied,5-very satisfied.
Time Frame
Postoperative period up to 48th hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for knee arthroplasty surgery under regional anesthesia ASA(American Society of Anesthesiology) 1-3 Receiving consent that accept regional analgesia Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
NUR CANBOLAT, MD
Phone
+90 532 516 25 83
Email
drnurekiz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GÜLBERK KILIÇ, MD
Organizational Affiliation
Istanbul Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nur Canbolat, Dr
Email
drnurekiz@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
33915199
Citation
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.
Results Reference
background
PubMed Identifier
30234517
Citation
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.
Results Reference
background
PubMed Identifier
32005622
Citation
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.
Results Reference
background
PubMed Identifier
34012290
Citation
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.
Results Reference
background

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

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