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Peri-articular Injection and (IPACK) With Adductor Canal Block in Total Knee Arthroplasty.

Primary Purpose

Postoperative Pain, Regional Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Adductor canal block (ACB) group
Peri-articular injection group
Adductor canal block and IPACK block group
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring peri-articular injection, adductor canal block, IPACK, Total knee arthroplasty

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients with severe osteoarthritis , ASA class I, II and III and scheduled for elective Total knee arthroplasty

Exclusion Criteria:

  • Patient who refuse the regional anesthesia technique.
  • History of allergy to local anesthetics.
  • Local infection at the site of the block.
  • Patients with bleeding and coagulation disorders.
  • Patient with Advanced renal, hepatic and cardiac diseases.
  • Preexisting lower extremity neurological abnormality, or neuropathy and difficulties in comprehending (NRS)

Sites / Locations

  • Tanta university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Adductor canal block (ACB) group

Peri-articular injection group

Adductor canal block and IPACK block group

Arm Description

Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal

Patients in group II will receive intraoperative peri-articular (cocktail) injection and will be performed by a single surgeon. A periarticular cocktail injection consisting of 90 mL of normal saline, 17.5 mL of 0.5% levobupivacaine, 2 mL of ketorolac (30 mg), and 0.5mg (0.5mL) of adrenaline, The total volume of the cocktail will be 110 mL

Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal IPACK block in which The ultrasound probe will be positioned in the popliteal crease, and needle will be inserted into the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur and 15 ml of 0.25% Levobupivacaine will be injected

Outcomes

Primary Outcome Measures

Post-operative pain
Post-operative pain will be assessed at rest and during physiotherapy by Numeric Rating Scale from (0-10) '0' representing "no pain" to '10' representing "worst pain imaginable"

Secondary Outcome Measures

Postoperative analgesia
Total analgesic consumption will be recorded
Duration of the block
Time till administration of first rescue analgesia will be recorded
Effect on Motor function
By recording the mean time taken to achieve 90o active knee flexion

Full Information

First Posted
May 5, 2020
Last Updated
October 13, 2021
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04396652
Brief Title
Peri-articular Injection and (IPACK) With Adductor Canal Block in Total Knee Arthroplasty.
Official Title
Comparison of Adductor Canal Block, Peri-articular Injection or Infiltration Between Popliteal Artery and Posterior Knee Capsule (IPACK) With Adductor Canal Block in Total Knee Arthroplasty.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta 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
This is a prospective randomized double blind controlled study to evaluate the post-operative analgesic effect of adductor canal block (ACB) or peri-articular injection (PAIs) compared to combined adductor canal block and infiltration of the interspace between popliteal artery and the capsule of posterior knee block ( IPACK) in patient undergoing total knee arthroplasty
Detailed Description
This prospective randomized study will be carried out in Tanta University Hospitals in Anesthesia Department for one year after approval from ethical committee of faculty of medicine of Tanta university. After approval from institutional ethics committee, an informed consent will be taken from each patient. All data of the patients will be confidential with secret codes and private file for each patient, all given data will be used for the current medical research only. Any unexpected risks encountered during the course of the research will be cleared to the participants as well as to the Ethical Committee on time. Every patient will receive an explanation to the purpose of the study and every patient will have a secret code number to ensure privacy to participants and confidentiality of data. Inclusion criteria: Adult patients with severe osteoarthritis , ASA class I, II and III and scheduled for elective Total knee arthroplasty will be enrolled in the study. Exclusion criteria: Patient who refuse the regional anesthesia technique. History of allergy to local anesthetics. Local infection at the site of the block. Patients with bleeding and coagulation disorders. Patient with Advanced renal, hepatic and cardiac diseases. Preexisting lower extremity neurological abnormality, or neuropathy and difficulties in comprehending (NRS). Grouping and Allocation: 60 patients will be enrolled in this study in each group, Patients will be randomly classified into three equal groups (20 patients each). Randomization will be done by computer generated numbers into: Group (I): 20 patients will receive adductor canal block alone. Group (II): 20 Patients will receive peri-articular injection alone. Group (III): 20 patients will receive adductor canal block (ACB) and infiltration of the interspace between popliteal artery and the capsule of posterior knee block (IPACK). Anesthetic technique: Preoperative assessment will be done by: History talking, clinical examination, routine laboratory investigations including CBC, coagulation profile, random blood sugar, liver and renal function tests. During the pre-anesthetic assessment, all patients will be familiarized with Numeric Rating Scale (NRS) score. On entering the operating room, intravenous line (IV) will be inserted, routine monitoring of heart rate by ECG, noninvasive blood pressure (NIBP), pulse oximetry will be done. All patients will receive spinal anesthesia with 3 ml 0.5% (15 mg) hyperbaric bupivacaine plus 25 μgm fentanyl at the L3/4 interspaces and the study of regional anesthetic technique will be performed postoperatively according to each group. All patients will receive postoperative analgesic regimen which is paracetamol 1gm intravenously every 8 hours and ketorolac 30mg every12 hours. Rescue analgesia in the form of 0.05 mg/kg of morphine IV will be administrated when the Numeric Rating Score (NRS) exceeding 3. The morphine dose will be repeated whenever indicated considering the total dose in the first 24 hours never exceeding 20 mg. Measurements: Demographic data (age, gender, weight, ASA classification). Post-operative pain will be assessed by Numeric Rating Scale (NRS) from 0 to 10 at 0,2,4,6 then every 6h for 24 hours and in the second and third postoperative days at rest and during Physiotherapy. Postoperative analgesia, which will be assessed by total analgesic consumption, and time till administration of first rescue analgesia will be recorded. Effect on Motor function: by recording the mean time taken to achieve 90o active knee flexion each day till the third postoperative day. Adverse effects: hypotension, Bradycardia, infection, hematoma and local anesthetic toxicity will be observed and treated accordingly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Regional Anesthesia
Keywords
peri-articular injection, adductor canal block, IPACK, Total knee arthroplasty

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled study
Masking
ParticipantOutcomes Assessor
Masking Description
The patients will be blind through the use of closed sealed envelops. The measurement will be collected by anesthesia nurse not participating in the study and blinded to its group.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adductor canal block (ACB) group
Arm Type
Experimental
Arm Description
Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal
Arm Title
Peri-articular injection group
Arm Type
Experimental
Arm Description
Patients in group II will receive intraoperative peri-articular (cocktail) injection and will be performed by a single surgeon. A periarticular cocktail injection consisting of 90 mL of normal saline, 17.5 mL of 0.5% levobupivacaine, 2 mL of ketorolac (30 mg), and 0.5mg (0.5mL) of adrenaline, The total volume of the cocktail will be 110 mL
Arm Title
Adductor canal block and IPACK block group
Arm Type
Experimental
Arm Description
Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal IPACK block in which The ultrasound probe will be positioned in the popliteal crease, and needle will be inserted into the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur and 15 ml of 0.25% Levobupivacaine will be injected
Intervention Type
Procedure
Intervention Name(s)
Adductor canal block (ACB) group
Intervention Description
Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal
Intervention Type
Procedure
Intervention Name(s)
Peri-articular injection group
Intervention Description
Patients in group II will receive intraoperative peri-articular (cocktail) injection and will be performed by a single surgeon. A periarticular cocktail injection consisting of 90 mL of normal saline, 17.5 mL of 0.5% levobupivacaine, 2 mL of ketorolac (30 mg), and 0.5mg (0.5mL) of adrenaline, The total volume of the cocktail will be 110 mL
Intervention Type
Procedure
Intervention Name(s)
Adductor canal block and IPACK block group
Intervention Description
Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal IPACK block in which The ultrasound probe will be positioned in the popliteal crease, and needle will be inserted into the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur and 15 ml of 0.25% Levobupivacaine will be injected
Primary Outcome Measure Information:
Title
Post-operative pain
Description
Post-operative pain will be assessed at rest and during physiotherapy by Numeric Rating Scale from (0-10) '0' representing "no pain" to '10' representing "worst pain imaginable"
Time Frame
After the resolution of the effect of spinal anesthesia for 72 hours postoperative
Secondary Outcome Measure Information:
Title
Postoperative analgesia
Description
Total analgesic consumption will be recorded
Time Frame
First 24 hours postoperatively
Title
Duration of the block
Description
Time till administration of first rescue analgesia will be recorded
Time Frame
First 24 hours postoperatively
Title
Effect on Motor function
Description
By recording the mean time taken to achieve 90o active knee flexion
Time Frame
Each day till the third postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients with severe osteoarthritis , ASA class I, II and III and scheduled for elective Total knee arthroplasty Exclusion Criteria: Patient who refuse the regional anesthesia technique. History of allergy to local anesthetics. Local infection at the site of the block. Patients with bleeding and coagulation disorders. Patient with Advanced renal, hepatic and cardiac diseases. Preexisting lower extremity neurological abnormality, or neuropathy and difficulties in comprehending (NRS)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed S Abdelghany, Lecturer
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta university
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
31528
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Once the study had been successfully completed, the data will be shared for other researchers

Learn more about this trial

Peri-articular Injection and (IPACK) With Adductor Canal Block in Total Knee Arthroplasty.

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